[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Michigan Rogel Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":568},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,43,65,89,114,133,152,175,200,220,241,264,282,305,330,351,374,395,415,440,464,483,502,521,545],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652379","an-artificial-intelligence-powered-supportive-care-chatbot-to-address-the-supportive-care-needs-of-young-adult-cancer-survivors-100652379",false,"NCT07772596","An Artificial Intelligence-Powered Supportive Care Chatbot to Address the Supportive Care Needs of Young Adult Cancer Survivors","Feasibility, Usability, and Acceptability of an AI-Powered MASCC Supportive Care Platform Among Young Adults With Cancer","Inclusion Criteria:\n\n* 18 - 39 years old\n* Able to speak\u002Fread English\n* Completed primary cancer treatment (e.g., surgery, radiation, chemotherapy, immunotherapy) at least one month prior to the time of consent. Although, participants will be eligible if they are receiving maintenance treatments\n* Report at least one moderate to severe symptom, side effect, or supportive care concern from cancer or its treatment\n* Able to access Wi-Fi\u002Finternet\n* Willing to complete surveys electronically\n\nExclusion Criteria:\n\n* Completed cancer treatment more than three years ago","ALL","18 Years","39 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This clinical trial studies whether an artificial intelligence (AI)-powered supportive care chatbot is helpful for addressing the supportive care needs of young adult cancer survivors. Young adult cancer survivors often experience ongoing and distressing symptoms following treatment, including extreme tiredness and lack of energy, anxiety, and difficulty sleeping. Young adult cancer survivors report a variety of strategies to self-manage these symptoms; however, there remains a gap in targeted interventions focused on the needs in young adult survivors. The AI-powered supportive care chatbot is designed to provide evidence-based information on supportive care for young adult cancer survivors. Users interact with the chatbot by entering free-text questions or selecting from predefined topics to receive tailored educational responses related to supportive care across the cancer continuum, including treatment effects, symptom management, care transitions, and life after cancer. The AI-powered supportive care chatbot may be an effective way to help address the supportive care needs of young adult cancer survivors.",[28,29],"Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm","NOT_YET_RECRUITING","2026-08-13",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":22},"2026-10-01",{"date":38,"type":22},"2028-10-01",{"name":40,"class":41},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100603140","early-phase-1-an-investigational-scan-68ga-ga-fapi-04-petct-for-the-imaging-of-patients-with-high-grade-neuroendocrine-cancer-100603140","NCT07132645","An Investigational Scan ([68Ga] Ga-FAPI-04 PET\u002FCT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer","An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):\n\n  * Previous low uptake of \\[68Ga\\] Ga-DOTATATE PET\u002FCT scan OR\n  * Krenning Score ≥ 3 OR\n  * Ki67 index ≥ 20%\n* Able to lie flat for 60 minutes\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Patient recently underwent surgery with wound healing",{"count":21,"type":22},[52],"EARLY_PHASE1","This early phase I trial determines where and to what degree the tracer \\[68Ga\\] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research \\[68Ga\\] Ga-FAPI-04. Because some cancers take up \\[68Ga\\] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.",[55],"Neuroendocrine Tumor","RECRUITING","2026-07-29",{"date":59,"type":34},"2026-07-31",{"date":61,"type":34},"2025-09-16",{"date":63,"type":22},"2027-09-01",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100602291","phase-2-personalized-neck-radiation-therapy-directed-by-sentinel-lymph-node-biopsy-for-the-treatment-of-oral-cavity-squamous-cell-carcinoma-precedent-trial-100602291","NCT07121595","Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial","PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patient must have biopsy-proven squamous cell carcinoma of the oral cavity\n* Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up:\n\n  * History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site\n  * Cross-sectional imaging of the head and neck within 42 days of study enrollment\n  * Cross-sectional imaging of the chest within 42 days of study enrollment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment\n* Age \\> 18\n* Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed\n* Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry\n* Women of childbearing potential and male participants must agree to use medically effect means of birth control throughout their participation in the treatment phase of the study\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease based on clinical or radiologic evaluation\n* Evidence of contralateral neck disease on staging imaging\n* Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years\n* Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed.\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection\n* Pregnant and breast-feeding patients\n* Excisional biopsy for study cancer\n* Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; incisional biopsy is permitted\n* Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \\[CLL\\]) or other active disease capable of causing lymphadenopathy (sarcoidosis or untreated mycobacterial infection)\n* Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy\n* Currently participating in another investigational therapeutic trial",{"count":73,"type":22},50,[75],"PHASE2","This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.",[78,79,80,81,82],"Oral Cavity Squamous Cell Carcinoma","Stage I Lip and Oral Cavity Cancer AJCC v8","Stage II Lip and Oral Cavity Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage IVA Lip and Oral Cavity Cancer AJCC v8",{"date":59,"type":34},{"date":85,"type":34},"2025-07-17",{"date":87,"type":22},"2030-07-01",{"name":40,"class":41},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":42},"100582665","phase-1-inulin-gel-in-combination-with-ipilimumab-and-nivolumab-for-the-treatment-of-metastatic-or-locally-advanced-kidney-cell-cancer-icon-trial-100582665","NCT06866262","Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial","Phase I\u002FII Trial of Inulin Gel in Combination With Ipilimumab and Nivolumab in Advanced Renal Cell Carcinoma [ICON Trial]","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age on the day of signing informed consent.\n* Candidate for ipilimumab and nivolumab therapy for metastatic renal cancer per the treating physician investigator.\n* Patient has a performance status of ≤ 2 on the Zubrod performance scale.\n* Patient has a histological or cytological diagnosis of renal cancer with clear cell or sarcomatoid component.\n* Radiologic or clinical evidence of metastatic disease, or progressive locally advanced disease.\n* Absolute neutrophil count ≥ 1,500\u002FuL.\n* Platelets ≥ 75K\u002FμL.\n* Hemoglobin ≥ 8.5 g\u002FdL.\n* Calculated creatinine clearance is ≥ 30 ml\u002Fmin as per the Cockroft-Gault formula.\n* Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) OR total bilirubin levels ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN.\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x ULN except for patients with liver metastases, AST\u002FALT should be ≤ 5 x ULN.\n* Patient received no prior systemic anti-cancer therapy for metastatic disease.\n* Patient has evaluable or measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Bone metastases, pleural effusion or ascites will be considered evaluable disease sites.\n\n  * Tumor mass: Must be accurately measurable in at least 1 dimension (longest diameter to be recorded) with a minimum size of:\n\n    * 10 mm by CT scan (CT scan slice thickness no greater than 5 mm,\n\nOr:\n\n* 20 mm by chest X-ray (if clearly defined and surrounded by aerated lung). With or without malignant lymph nodes: ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness must be ≤ 5 mm). The measurement should be two dimensions at axial plane. The short axis should be in perpendicular to long diameter.\n\n  * Ability to understand and the willingness to review and sign a written informed consent.\n  * Both male and female patients must agree to use adequate contraceptive measures to prevent pregnancy throughout the duration of study therapy and a minimum of -5 months after stopping therapy per package insert of ipilimumab and nivolumab.\n  * Ability to ingest oral therapy.\n  * Female patient of childbearing capacity has a negative pregnancy test within 7 days of starting study therapy.\n\nExclusion Criteria:\n\n* The subject has received cytotoxic therapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) or immunosuppressants (excluding steroids) within 4 weeks or antibiotics within 2 weeks of starting study therapy.\n* Patient is currently enrolled in another clinical trial testing another investigational agent, or concurrently in another approved systemic anti-cancer therapy for renal cancer.\n* Patient is on chronic systemic steroid therapy at doses \\> 10 mg\u002Fday prednisone equivalent or on any other immunosuppressive therapy within 7 days prior to day 1 of therapy. Exception-Replacement steroid doses for adrenal insufficiency are permitted as necessary.\n* Subjects with active and uncontrolled autoimmune disease. Subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate CNS specific treatment at the time of study registration. Patients who have completed CNS therapy prior to starting therapy and clinically stabilized are also eligible.\n* Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating investigator.\n* Patient has known psychiatric or substance abuse disorders that, in the opinion of the investigator, would interfere with cooperation with the requirements of the trial.\n* Pregnant patients or patients planning donation of sperm or breast milk during the therapy and for a minimum of 5 months after stopping therapy.\n* Lactating patients if they do not agree to discontinue breast feeding through the entire duration of study participation and for 5 months after stopping therapy.\n* History of another metastatic\u002Frelapsed active malignancy. Localized skin cancers such as basal cell or squamous cell cancer are allowed.\n* Intractable nausea and vomiting refractory to therapy with antiemetics.\n* History of hypersensitivity to ipilimumab, nivolumab, inulin or the formulations excipients.\n* Known diagnosis of malabsorption disorder.\n* Concurrent use of probiotics or antibiotics.\n* Patients with a history of colectomy and\u002For gastric bypass.\n* Patients with a known diagnosis of active inflammatory bowel disease or irritable bowel syndrome.\n* History of organ transplant or stem cell\u002Fbone marrow transplant.\n* Patients with active Clostridium difficile infection within 3 months before therapy start. Active infection is defined as a stool sample positive for Clostridium difficile toxin by enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.",{"count":97,"type":22},55,[99,75],"PHASE1","This phase I\u002FII trial tests the safety and effectiveness of inulin gel in combination with ipilimumab and nivolumab in treating patients with kidney cell cancer (renal cell carcinoma \\[RCC\\]) that has spread from where it first started (primary site) to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced). Inulin is a common food additive fermentable prebiotic fiber beneficial for a healthy gut microbiome. The microbiome is the collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live on and inside the body. Inulin may also be used for cancer prevention and heart health, but there is less evidence to support those uses. The gut microbiome profile may improve the effectiveness of drugs called immune checkpoint inhibitors, such as ipilimumab and nivolumab. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving inulin gel in combination with ipilimumab and nivolumab may be safe and effective in treating in patients with metastatic or locally advanced RCC.",[102,103,104,105,106,107],"Locally Advanced Clear Cell Renal Cell Carcinoma","Locally Advanced Sarcomatoid Renal Cell Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8",{"date":59,"type":34},{"date":110,"type":34},"2025-08-15",{"date":112,"type":22},"2031-08-01",{"name":40,"class":41},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":42},"100293399","phase-2-cyclophosphamide-and-sirolimus-for-the-treatment-of-metastatic-rai-refractory-differentiated-thyroid-cancer-100293399","NCT03099356","Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer","An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer","Inclusion Criteria:\n\n* Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment\n* Measurable disease (\\>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation.\n* Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician.\n* Age ≥ 18 years\n* ECOG (Eastern Cooperative Oncology Group) performance status 0-2\n* Life expectance of ≥ 12 weeks\n* 131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)\n* Adequate organ and marrow function\n* Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment\n* Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing\n* Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks\n* Prior experimental therapy within 4 weeks of planned start of this trial\n* 131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)\n* Previous treatment with an mTOR inhibitor\n* Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least one week prior to the start of treatment with Cyclophosphamide and Sirolimus\n* Impairment of GI (gastrointestinal) function or GI disease that may significantly alter the absorption of study medications (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) including dependence on a G-Tube for administration of medications.\n* A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment\n* Patients with known sensitivities to either cyclophosphamide and\u002For sirolimus\n* Patients with known urinary outflow obstruction\n* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol\n* Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence\n* Women who are pregnant or breast-feeding\n* Patients residing in prison",{"count":122,"type":22},22,[75],"This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.",[126],"Metastatic Thyroid Cancer",{"date":59,"type":34},{"date":129,"type":34},"2017-04-27",{"date":131,"type":22},"2026-12",{"name":40,"class":41},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":42},"100207190","quantitative-mri-for-myelofibrosis-100207190","NCT01973881","Quantitative MRI for Myelofibrosis","Quantitative MRI for Myelofibrosis - MRI Parameters as Biomarkers for Analyzing Extent of Disease and Measuring Response to Treatment","Inclusion Criteria:\n\n1. Male \u002Ffemale subjects over the age of 18\n2. Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.\n3. No contraindications to MRI\n4. Able to undergo MRI without anesthesia\n\n   \\-\n\nExclusion Criteria:\n\n1. Patients with pacemakers or other implanted magnetic devices that may malfunction or move because of the strong magnetic field inside the MRI room and scanner.\n2. Any prior adverse event associated with MRI that is not related to injection of contrast agents or other medicines.\n\n   \\-","99 Years",{"count":142,"type":22},192,"OBSERVATIONAL","This study is for the development and validation of functional magnetic resonance imaging (MRI) parameters as biomarkers for analyzing extent of disease and quantifying response to treatment in patients with myelofibrosis.",[146],"Myelofibrosis",{"date":59,"type":34},{"date":149,"type":34},"2014-12-22",{"date":131,"type":22},{"name":40,"class":41},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":159,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":42},"100649649","phase-1-arsenic-trioxide-to-prevent-relapse-in-patients-undergoing-allogeneic-stem-cell-transplantation-for-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100649649","NCT07737769","Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome","A Phase I Non-Randomized Study of TP53 Reactivation With Arsenic Trioxide in Allogeneic Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome","Inclusion Criteria:\n\n* AML or MDS patients eligible to receive first allogeneic HCT. Eligibility inclusion for HCT is defined as per University of Michigan bone marrow transplant (BMT) standard of care criteria\n* Presence of high-risk AML\u002FMDS with probable biallelic TP53 deletion or mutation status, defined by one of the following in prior blood or bone marrow assessments:\n\n  * TP53 loss by karyotype (chromosome 17 or 17p deletion) or single nucleotide polymorphism (SNP) (Cancer Microarray) AND ≥ one clonal TP53 mutation by next generation sequencing (NGS) (VAF \\> 10%).\n  * ≥ one TP53 mutation by NGS testing (with VAF \\> 40%)\n  * ≥ two distinct TP53 mutation(s) by NGS (VAF \\>10%)\n* Evidence that at least one TP53 allele harbors a structural TP53 missense mutation. In cases where the mutation type is unclassified, molecular pathology assessment is required to determine if one of the lesions is a missense mutation (as described in NGS report)\n* Patients may be enrolled with either active disease or in morphological remission, provided the bone marrow blast count on the pre-HCT assessment does not exceed 30%\n* Age \\> 21 years at enrollment and receiving allogeneic HCT in the adult transplant program\n* Karnofsky performance score (KPS) ≥ 70%\n* Documentation of adequate pulmonary function by forced expiratory volume and 1 second (FEV1) ≥ 50% of predicted, forced vital capacity (FVC) ≥ 50% of predicted and DLCO (corrected for hemoglobin) ≥ 50% of predicted (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Transthoracic echocardiogram with ejection fraction ≥ 50% (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Estimated glomerular filtration rate ≥ 50% ml\u002Fmin\u002F1.73m\\^2 by the Cockcroft-Gault equation. Glomerular filtration rate (GFR) should be corrected for body surface area (BSA) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Total bilirubin ≤ 2 x upper limit of normal (unless directly attributed to Gilbert's Syndrome) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Electrocardiogram (ECG) with corrected QT (QTc) ≤ 450 msec (using the Framingham correction) (must meet all criteria at time of enrollment based on standard of care pre HCT testing)\n* Availability of an 8 of 8 HLA matched unrelated donor with matching at HLA A, B, C and DRB1\n* Availability of a peripheral blood stem cell (PBSC) product\n* Ability to understand and the willingness to sign a written informed consent\n* Willingness to agree to use adequate contraception methods (subjects of reproductive potential only):\n\n  * Females of reproductive potential must agree to use effective contraception (e.g., hormonal contraception, intrauterine device, tubal occlusion, vasectomized partner, abstinence) during treatment with ATO and for 6 months after the final dose.\n  * Males with female partners of reproductive potential must agree to use effective contraception during treatment with ATO and for 3 months after the final dose\n\nExclusion Criteria:\n\n* Uncontrolled infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and\u002For culture) that the infection is well controlled\n* Patients may NOT have evidence or symptoms of central nervous system (CNS) disease at the time of enrollment\n* HIV or human t-lymphotropic virus (HTLV) 1 \u002F HTLV 2 (seropositivity and\u002For polymerase chain reaction \\[PCR\\] positivity)\n* Pregnant and nursing mothers are excluded\n* Any physical, psychological or psychosocial condition that, in the opinion of the investigator, would pose unacceptable risk to the patient\n* Other malignancy requiring systemic therapy or with life expectancy of \\\u003C 1 year\n* Receipt of prior allogeneic HCT\n* History of severe cardiac conduction abnormalities (complete heart block, Left Bundle Branch Block, Torsades de Pointes, or other ventricular arrythmias). History of any cardiac arrhythmia (e.g. rate controlled atrial fibrillation) is not an exclusion\n* QTc \\> 450 msec (using the Framingham correction)\n* Patients under 40 years of age at time of evaluation will be screened for Shwachman-Diamond syndrome (SDS), which is a rare, inherited disorder characterized primarily by exocrine pancreatic insufficiency, bone marrow failure, and skeletal abnormalities. These patients commonly progress to myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Given potential for increased liver toxicities in this population, these patients will be excluded from the study. All patients under 40 years old will be screened through the University of Michigan Prevention Genetics Clinic prior to enrollment\n* Patients with known hypersensitivity to arsenic","21 Years",{"count":161,"type":22},20,[99],"This phase I trial tests the safety, side effects, best dose and how well arsenic trioxide works to prevent relapse in patients undergoing allogenic stem cell transplantation for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Chemotherapy drugs, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving arsenic trioxide may be safe, tolerable and\u002For effective in preventing relapse in patients undergoing allogenic stem cell transplant for AML or MDS.",[165,166],"Acute Myeloid Leukemia","Myelodysplastic Syndrome","2026-07-27",{"date":169,"type":34},"2026-07-30",{"date":171,"type":22},"2026-11",{"date":173,"type":22},"2029-11",{"name":40,"class":41},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":181,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":42},"100600400","spectct-imaging-for-dosimetry-in-177lu-psma-617-pluvicto-therapy-100600400","NCT07096999","SPECT\u002FCT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy","Inclusion Criteria:\n\n* \\* 177Lu-617 PSMA treatment scheduled for mCRPC\n\n  * Clinically stable as determined by the nuclear medicine clinicians\n  * Male\n  * ≥ 18 years of age\n  * Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed","MALE",{"count":183,"type":22},60,"This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy",[186],"Metastatic Castration-Resistant Prostate Carcinoma",[188,189,190,191,192],"Prostate Cancer","177Lu","PSMA","mCRPC","Radioligand Therapy","2026-07-24",{"date":167,"type":34},{"date":196,"type":34},"2025-01-23",{"date":198,"type":22},"2031-01-23",{"name":40,"class":41},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":42},"100576364","phase-2-phase-ii-study-of-resistant-potato-starch-plus-deferasirox-to-improve-outcomes-in-patients-undergoing-allogeneic-stem-cell-transplantation-100576364","NCT06784336","Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation","Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen\n* Age ≥18 years\n* Karnofsky performance status \\>70%, see Appendix A\n* Patients must be able to swallow capsules\u002Ftablets\n* Ability to understand and the willingness to sign a written informed consent\n* Availability of a full-HLA matched related or unrelated donor who is medically eligible to donate cells according to the National Marrow Donor Program criteria\n\nExclusion Criteria:\n\n* Patients with active inflammatory bowel disease requiring treatment per treating investigator\n* Patients with a history of gastric bypass surgery\n* Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon\n* Patients with active iron deficiency anemia requiring treatment\n* Patients with iron overload receiving active treatment with deferasirox\n* Known hypersensitivity to deferasirox or any component of Jadenu or Exjade\n* Patients actively enrolled on treatment or in follow up phase on any other GVHD prevention trial\n* Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures",{"count":73,"type":22},[75],"The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.",[211],"Allogeneic Stem Cell Transplant","2026-07-19",{"date":214,"type":34},"2026-07-21",{"date":216,"type":34},"2025-10-15",{"date":218,"type":22},"2029-10",{"name":40,"class":41},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":42},"100644683","transcranial-direct-current-stimulation-for-the-treatment-of-chemotherapy-induced-peripheral-neuropathy-in-cancer-survivors-100644683","NCT07673614","Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors","Improving Sensorimotor Function in CIPN: A Randomized, Sham Controlled, Double Blinded, Crossover Mechanistic Trial of Transcranial Direct Current to the Sensorimotor Cortex","Inclusion Criteria:\n\n* 18 to 85 years of age\n* Diagnosis of cancer, stages I-IV\n* Cancer survivor (not currently receiving chemotherapy, radiation, or immunotherapy)\n* Presence of CIPN defined as new, length-dependent numbness, tingling, and\u002For pain that developed with neurotoxic chemotherapy\n* CIPN20 score ≥ 20\n* Able to walk unassisted\n* Proficient in English\n\nExclusion Criteria:\n\n* Known brain metastases\n* Known neurological conditions aside from chemotherapy-induced peripheral neuropathy (CIPN)\n* History of brain or spinal surgery\n* Neuropathy other than CIPN\n* Significant hearing or vision deficits\n* Vestibulopathy\n* Currently receiving chemotherapy, radiation therapy, or immunotherapy\n* Contraindications to transcranial direct current stimulation (tDCS), including recent seizures\n* Presence of metallic objects in the head\n* Presence of specific implanted medical devices (e.g., deep brain stimulator, cochlear implant, vagus nerve stimulator, spinal cord stimulator, pacemakers, and intracardiac devices)\n* Active scalp dermatological conditions","85 Years",{"count":73,"type":22},[25],"This clinical trial tests how well a type of non-invasive brain stimulation called transcranial direct current stimulation (tDCS) works to treat chemotherapy induced peripheral neuropathy (CIPN) in cancer survivors. CIPN is numbness, tingling, pain, and movement problems that can develop after chemotherapy as a result of changes to the nerves. A non-invasive form of brain stimulation called tDCS, applied to the area of the brain involved in sensation and movement, can temporarily improve the ability to detect vibration and temperature, as well as balance and walking, which may improve sensation and reduce pain in cancer survivors with CIPN.",[232,28,29],"Chemotherapy-Induced Peripheral Neuropathy","2026-07-16",{"date":235,"type":34},"2026-07-17",{"date":237,"type":22},"2026-08-01",{"date":239,"type":22},"2028-02",{"name":40,"class":41},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":42},"100633887","phase-1-pomalidomide-after-car-t-cell-therapy-for-the-treatment-of-relapsed-or-refractory-cd19-b-cell-leukemia-or-lymphoma-100633887","NCT07532525","Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma","A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed\u002FRefractory CD19+ B-Cell Leukemias and Lymphomas","Inclusion Criteria:\n\n* Subject must have had a histologically or cytologically confirmed R\u002FR CD19+ B-cell leukemia or lymphoma and have received a commercially available CAR-T product approved to treat R\u002FR CD19+ Bcell leukemias and lymphomas.\n* Subject must be 28 - 56 days post infusion of CD19CART product at time of enrollment.\n* \\>= 18 years in age at time of enrollment\n* Subject is able to swallow pills\u002Ftablets\n* Karnofsky performance score of \\>= 50%\n* Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (granulocyte colony stimulating factor allowed)\n* Platelets \\>= 50,000\u002Fmm\\^3 (transfusion independent for \\>= 7 days, defined as not receiving platelet transfusions for at least 7 days prior to enrollment, unless due to marrow involvement from primary malignancy \\[thrombopoietin (TPO) mimetics allowed\\])\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) per institution\n* Alanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) =\\\u003C 3 x institutional ULN per institution\n* Serum albumin \\>= 2.0 g\u002FdL\n* Creatinine clearance (Cockcroft-Gault equation) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n* Sexually active females capable of becoming pregnant and males must agree to participate in the pomalidomide Risk Evaluation and Mitigation Strategy (REMS) program\n* Patients must agree not to donate blood during treatment with pomalidomide and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to pomalidomide\n* Co-Enrollment: Willingness to consent\u002F co-enroll on BMT long term follow up study, HUM00043287 (UMCC2001-0234)\n\nExclusion Criteria:\n\n* Patients with known progressive or refractory disease.\n* The following transplant or CAR T-related events are excluded:\n\n  * Active grade \\>= 2 acute or chronic graft versus host disease (GVHD)\n  * Active cytokine release syndrome (CRS) grade \\>= 2\n  * Active immune effector cell associated neurotoxicity (ICANS) grade \\>= 2\n* Subject receiving \\>= 0.25 mg\u002Fkg\u002Fday of methylprednisolone equivalent. Subject being treated with medications with a known major drug interaction to pomalidomide. Specifically, patients receiving CYP1A2 inhibitors, such as ciprofloxacin, omeprazole, cimetidine, estrogen, and fluvoxamine.\n* Patient who smokes cigarettes.\n* Subject must not have initiated or received intervening therapy for a primary or secondary malignancy within 28 days of study enrollment, including, a) myelosuppressive chemotherapy, b) biologic anti-neoplastic agents (e.g., ruxolitinib, imatinib, dasatinib…), or checkpoint inhibitors (e.g., pembrolizumab). The use of cytokine inhibition for management of CRS\u002FICANS is allowed within the prior 28 days\n* Receipt of radiation therapy (XRT) (focal or large field, including cranial or cranial-spinal) within 28 days prior to enrollment\n* Stem cell transplant or rescue following most recent CD19CART therapy\n* History of allergic reactions to pomalidomide or any of the excipients and any similar compounds\n* Intercurrent illness or conditions:\n\n  * Patients with uncontrolled infections. In addition, patients with any documented bacteremia, fungemia, or new onset viremia that requires antimicrobial therapy within 72 hours prior to enrollment. Empiric antimicrobials are allowed\n  * Active grade \\>= 4 gastrointestinal, hepatic, pulmonary, renal, cardiac toxicity by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. Patients requiring dialysis are excluded\n  * Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, severe congenital neutropenia, Schwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome are not excluded\n  * History of known prior arterial thromboembolism, venous thromboembolism, pulmonary embolism, cardiovascular accidents, or myocardial infarctions within 3 months prior to enrollment\n* Pregnant women are excluded from this study. Women should discontinue breastfeeding during treatment and for at least 4 weeks after discontinuation of study drug\n* HIV positivity within 8 weeks of screening on polymerase chain reaction (PCR) based assay",{"count":249,"type":22},12,[99],"This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia\u002Flymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.",[253,254,255,256],"Recurrent B Acute Lymphoblastic Leukemia","Recurrent B-Cell Non-Hodgkin Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory B-Cell Non-Hodgkin Lymphoma","2026-07-14",{"date":233,"type":34},{"date":260,"type":22},"2026-09-01",{"date":262,"type":22},"2028-10",{"name":40,"class":41},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":271,"maxAge":19,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":42},"100588432","solution-focused-brief-therapy-for-support-of-psychological-distress-in-adolescent-and-young-adult-cancer-survivors-100588432","NCT06941324","Solution-Focused Brief Therapy for Support of Psychological Distress in Adolescent and Young Adult Cancer Survivors","SFBT for AYA Cancer Survivors' Psychological Distress: Evaluating Solution-Focused Brief Therapy as a Strength-Based Psychotherapeutic Intervention for Psychological Distress in Adolescents and Young Adults With Cancer","Inclusion Criteria:\n\n* 15 - 39 years old\n* Diagnosed with cancer\n* Receiving active cancer care (6 weeks post initial diagnosis to control for emotional responses to normative stressors) or within 5 years of post-treatment survivorship\n* Experiencing psychological distress (i.e., a t-score \\>= 57 on the Brief Symptom Inventory - 18 items \\[BSI-18\\])\n* Fluent in English\n\nExclusion Criteria:\n\n* End-of-life care\n* \\> 5 years into the post-treatment survivorship\n* Major physical challenges (e.g., hearing loss, developmental delay)\n* Acute mental health conditions (e.g., active psychosis, suicide risk)\n* Receiving or newly initiated psychotherapy for psychological distress during the study period","15 Years",{"count":183,"type":22},[25],"This clinical trial evaluates the how well a virtually delivered solution-focused brief therapy (SFBT-C) works to decrease adolescent and young adult cancer survivors' psychological distress in comparison to enhanced treatment-as-usual care. Cancer and its treatment can have immediate and long-term impacts on adolescent and young adult cancer survivor's lives, including education and employment, financial stability, sexual health, and social, romantic, and family relationships. Consequently, many adolescent and young adult cancer survivors report psychological distress, often manifesting as depression and anxiety, and may benefit from psychotherapy to improve their engagement with medical treatment and overall quality of life. SFBT-C is a theory-driven and brief hope-based psychotherapy designed for the unique psychosocial needs facing adolescent and young adult cancer survivors. Undergoing SFBT-C may work better than treatment-as-usual care for the support of psychological distress in adolescent and young adult cancer survivors.",[28,29],{"date":233,"type":34},{"date":278,"type":34},"2025-06-23",{"date":280,"type":22},"2028-07-01",{"name":40,"class":41},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100543460","phase-2-study-of-neoadjuvant-enfortumab-vedotin-and-pembrolizumab-in-upper-tract-urothelial-cancer-100543460","NCT06356155","Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer","A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer (NEPTUNE)","NEPTUNE","Inclusion Criteria:\n\n* Patients must have a diagnosis of high-grade upper tract (renal pelvis and\u002For ureter) urothelial carcinoma proven by biopsy or cytology within 60 days prior to registration with the following (cT1-4 N0-1 M0): a. Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. b. No regional lymph node metastasis, a single regional lymph node metastasis, or multiple regional lymph node metastases (no distant lymph node metastases)\n* Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥50%) subtype is urothelial carcinoma.\n* Patients must be considered to be a candidate for definitive surgery (nephroureterectomy or distal ureterectomy) with curative intent by the treating urologist. Lymph node dissection is strongly encouraged but its scope and determination will be at the discretion of the treating urologist. Details of the surgery such as bladder cuff removal are left to the discretion of the treating urologist. Robotic or open approaches are allowed.\n* Prior local endoscopic therapy for upper tract urothelial cancer is permitted if completed at least 6 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or resolved.\n* Prior uro-oncologic history: a. History of or active non-invasive carcinoma or carcinoma in situ of the bladder\u002Furethra or upper tract is allowed. b. Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG. c. Prior neoadjuvant or adjuvant chemotherapy or antibody-drug conjugate for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥ 1 year prior to study registration.\n* Patients must be age ≥ 18 on the date of registration.\n* ECOG Performance Status 0-1.\n* Criteria for patients with hepatitis B or C are listed below. Hepatitis B and C screening tests are not required unless there is a known history of HBV or HCV infection or as mandated by local healthy authority. Hepatitis B positive subjects • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment.\n* Patients must have adequate organ and bone marrow function as defined in Table 1. Specimens must be collected within 14 business days prior to start of study enrollment.\n* Women and men of reproductive potential must agree to use an effective contraceptive method during treatment and for 4 months after the last dose of study drug. See Section 16.3, Appendix 3. Men must also refrain from donating sperm during this period.\n* Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration and are not breastfeeding.\n* Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the treating oncologist.\n* All patients must be informed of the investigational nature of this study. The patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a legally authorized representative or caregiver and\u002For family member available will also be considered eligible.\n\nExclusion Criteria:\n\n* Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4), anti-PD1, anti-PD-L1, anti-PD-L2 antibodies, and therapeutic anticancer vaccines.\n* Prior exposure to monomethyl auristatin E antibody-drug conjugates (MMAE ADC).\n* Patient is currently on or used immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion: o Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection). o Use of chronic immunosuppressive agents at baseline at doses not to exceed more than prednisone 10 mg\u002Fday or equivalent. o Steroids as premedications for hypersensitivity reactions (e.g., CT scan premedication).\n* Active or prior documented autoimmune or inflammatory disorders requiring immunosuppressive therapy within 2 years prior to registration. Exceptions are well-controlled hyper\u002Fhypothyroidism, celiac disease controlled by diet alone, diabetes mellitus type 1, alopecia, psoriasis, eczema, lichen planus, vitiligo, or similar skin\u002Fmucosa conditions.\n* Evidence of metastasis (M1) on axial imaging at baseline.\n* History of invasive, node positive, or metastatic bladder cancer OR invasive contralateral upper tract cancer within 2 years prior to registration.\n* Enrolled in another interventional clinical trial at the time of registration.\n* Patient has another active malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 1 year. The time requirement does not apply to participants who underwent successful definitive resection of non-melanoma skin cancers, superficial bladder cancer (described above in inclusion criteria 6), in situ cervical cancer, other in situ cancers, or either clinically insignificant per the investigator (e.g., ≤Gleason 3+4) on surveillance or previously treated prostate cancer without rising PSA and no plan to treat. NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patient has one kidney.\n* Patient is pregnant or lactating.\n* Has severe hypersensitivity (≥ Grade 3) to enfortumab vedotin, pembrolizumab, and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogenic tissue (e.g., hematopoietic stem cell transplant HSCT)\u002Fsolid organ transplant.\n* Has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment.\n* Has known active keratitis or corneal ulcerations\n* Has any of the following: a. Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria outlined in Table 1). b. Uncontrolled diabetes mellitus as deemed by Hemoglobin A1c of 8 or greater. c. Grade ≥ 2 peripheral neuropathy. d. New York Heart Association Class III or higher heart failure",{"count":291,"type":22},32,[75],"This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in patients with high-grade localized\u002Flocally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.",[295],"Urothelial Carcinoma",[297],"Neoadjuvant",{"date":233,"type":34},{"date":300,"type":34},"2025-07-22",{"date":302,"type":22},"2028-03",{"name":40,"class":41},2,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":312,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100515792","phase-1-study-of-ribociclib-administered-concurrently-with-postoperative-radiation-therapy-in-patients-with-high-risk-hrher2--breast-cancer-100515792","NCT05996107","Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+\u002FHER2- Breast Cancer","A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n* ER and\u002For PR-positive (≥ 1% positivity as determined by local pathology laboratory), HER2-negative breast cancer with \\> 3 lymph nodes involved on sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) OR have between 1-3 lymph nodes involved AND have T3 disease OR have between 1-3 lymph nodes involved and grade 3 breast cancer.\n* Age ≥ 18\n* Patients must have undergone gross total excision of all locoregional disease with negative margins (i.e. no tumor on ink). At least 21 days must elapse between surgical treatment for breast cancer and initiation of study treatment.\n* Patients must have completed chemotherapy (either in neoadjuvant or adjuvant setting). If received adjuvant chemotherapy, chemotherapy must have completed at least 21 days prior to initiation of study treatment.\n* Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and surgical side effects following definitive breast surgery except for neuropathy and alopecia\n* Adequate baseline hematologic, hepatic and renal function as indicated below:\n\n  * Patient has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by central laboratory for eligibility):\n  * Absolute neutrophil count ≥ 1.5 × 109\u002FL\n  * Platelets ≥ 100 × 109\u002FL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * INR ≤1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)\n  * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula\n  * Total bilirubin \\\u003C ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.\n  * Aspartate transaminase (AST) \\\u003C 2.5 × ULN, except for patients with liver metastasis, who are only included if the AST is \\\u003C 5 × ULN\n  * Alanine transaminase (ALT) \\\u003C 2.5 × ULN, except for patients with liver metastasis, who are only included if the ALT is \\\u003C 5 × ULN\n  * Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of study medication:\n  * Potassium\n  * Magnesium\n  * Total Calcium (corrected for serum albumin)\n* QTcF interval at screening EKG ≤ 450ms (QT interval using Fridericia's correction).\n* Mean resting heart rate 50-90 bpm (determined from the EKG).\n* Ability to swallow study drug (Ribociclib).\n* ECOG Performance Status 0-1 (Karnofsky \\> 60%).\n* Availability of archival tumor tissue from surgical specimen.\n* Ability to understand and willingness to sign informed consent.\n* Women of childbearing potential must have confirmed negative pregnancy test (urine or serum) within 14 days of initiation of study treatment.\n\nExclusion Criteria:\n\n* Prior history of radiation therapy to the chest wall and\u002For regional nodes is not allowed (but prior radiation therapy to other sites is permissible).\n* Prior history of CDK4\u002F6 inhibitor therapy.\n* Patients who are pregnant or breastfeeding.\n\n  • Because radiation is known to be teratogenic, women of childbearing potential must have a documented negative pregnancy test performed prior to the start of study therapy (as above) and agree to use adequate contraception (hormonal or double barrier method of birth control; vasectomized partner; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Patient with distant metastases of breast cancer beyond regional lymph nodes and\u002For evidence of breast cancer recurrence prior to study enrollment.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n  * History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.\n  * Documented cardiomyopathy.\n  * Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n  * Risk factors for Torsades de Pointes (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia.\n  * Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment).\n  * Inability to determine the QTcF interval.\n  * Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block).\n  * Uncontrolled arterial hypertension with systolic blood pressure \\> 160 mmHg.\n* Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years. Questions regarding inclusion of individual subjects should be directed to Drs. Cobain and Speers (ecobain@med.umich.edu and cspeers@med.umich.edu).\n* Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible.\n* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).\n* Patients must not receive any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy.\n* Patient is currently receiving any of the following substances within 7 days before randomization:\n\n  * Concomitant medications, herbal supplements, and\u002For fruits (e.g. grapefruit, pummellos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4\u002F5.\n  * Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.","FEMALE",{"count":21,"type":22},[99],"The purpose of this research study is to determine the safety, tolerability and dose of Ribociclib when combined with adjuvant radiation in women with high-risk ER+ breast cancer.\n\nOnce enrolled on study, patients will begin treatment with Ribociclib 400 mg daily at the same time as they initiate standard of care adjuvant radiation therapy- 50 Gy in 25 fractions or 42.56 Gy in 16 fractions +\u002F- 10 Gy boost including comprehensive nodal. Paitents will continue treatment with Ribociclib for up to 6 weeks.",[317],"Breast Cancer",[319,320,321],"HR+\u002FHER2-","Node positive","High-Risk breast cancer",{"date":323,"type":34},"2026-07-15",{"date":325,"type":34},"2024-02-27",{"date":327,"type":22},"2030-10",{"name":40,"class":41},3,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":42},"100639280","office-based-ureteroscopy-utilizing-a-single-use-digital-flexible-ureteroscope-for-upper-tract-urothelial-carcinoma-100639280","NCT07630155","Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma","A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex\n* History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment\n* Ability and willingness to complete and adhere to survey questions and responses throughout study duration\n\nExclusion Criteria:\n\n* Known ureteral strictures\n* Active urinary tract infection\n* Need for general anesthesia due to patient or procedural factors\n* History of inability to tolerate ureteroscopy under local anesthetic\n* Anticipated need for laser ablation during the surveillance procedure\n* Pregnancy",{"count":338,"type":22},10,[25],"This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.",[342],"Renal Pelvis and Ureter Urothelial Carcinoma","2026-07-09",{"date":345,"type":34},"2026-07-10",{"date":347,"type":22},"2026-08",{"date":349,"type":22},"2027-08",{"name":40,"class":41},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":312,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":373,"locationsCount":42},"100453329","phase-4-pharmacokinetic-study-of-skeletal-muscle-area-based-paclitaxel-infusion-in-patients-with-cancer-100453329","NCT05183126","Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Inclusion Criteria:\n\n* Planned paclitaxel 80 mg\u002Fm\\^2, 1-hour infusion\n* Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w\u002Fin 1 year)\n* Female\n* ≥ 18 years old\n* Adequate organ function to receive paclitaxel treatment as defined in the protocol\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.\n* History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length\n* Pregnant or nursing\n* Receiving any other dose (i.e., not 80 mg\u002Fm2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason",{"count":122,"type":22},[360],"PHASE4","The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low\u002Fsarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low\u002Fsarcopenic SMA normalizes the levels to those of patients with normal SMA.",[317,363,364],"Metastatic Gastric Cancer","Esophageal Cancer",[366],"pharmacokinetics","2026-07-01",{"date":369,"type":34},"2026-07-02",{"date":371,"type":34},"2022-03-28",{"date":171,"type":22},{"name":40,"class":41},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":329},"100433512","localized-leiomyosarcoma-biomarker-protocol-100433512","NCT04925089","Localized Leiomyosarcoma Biomarker Protocol","Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy","Inclusion Criteria:\n\n* Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum\n* Grade 2 or 3, or high-grade LMS\n* Tumor size \\>5 cm in greatest dimension\n* Primary tumor amenable to complete resection\n* There is no age requirement\n* Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy\n* If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered\n* Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\\&E stained slide) from diagnostic or pre-treatment biopsy available for study research",{"count":382,"type":22},40,"* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).\n* Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.\n* Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.\n* Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival\n* Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.\n* Circulating tumor DNA (ctDNA) is present in blood of patients with advanced\u002Fmetastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.\n* A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.",[385],"Leiomyosarcoma",[387,388,389],"ctDNA","radiomics","biomarker",{"date":369,"type":34},{"date":392,"type":34},"2023-04-26",{"date":171,"type":22},{"name":40,"class":41},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":42},"100646917","phase-1-escalating-cycle-1-dose-of-lu-177-psma-617-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-100646917","NCT07682649","Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer","A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial","ESCENDO","Inclusion Criteria:\n\n* Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET\u002FCT scan positive (lesion uptake \\> liver uptake by visual assessment)\n* Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.)\n* Patients must be ≥18 years of age\n* Patients must have an ECOG performance status of 0 or 1\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3\n* Platelet count ≥ 150,000\u002Fmm\\^3\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Estimated glomerular filtration rate (EGFR) ≥ 60ml\u002Fmin\n* Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases\n* Albumin \\> 3.0 g\u002FdL\n* Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Does not meet criteria for standard Lu-177-PSMA-617 RLT\n* Diffuse marrow involvement evident on Ga-68-PSMA PET\u002FCT as assessed by study treating clinician\n* Prior RLT\n* Unmanageable concurrent bladder outflow obstruction or urinary incontinence\n* Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation\n* Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy\n* Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT",{"count":161,"type":22},[99],"This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.",[186,407],"Stage IVB Prostate Cancer AJCC v8","2026-06-26",{"date":410,"type":34},"2026-07-06",{"date":237,"type":22},{"date":413,"type":22},"2031-08",{"name":40,"class":41},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":422,"maxAge":19,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":42},"100633622","personalized-cancer-support-thrive-track-to-manage-the-emotional-needs-of-young-adults-with-thyroid-melanoma-and-testicular-cancer-percs-ya-trial-100633622","NCT07529080","Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial","Personalized Cancer Support for Young Adults","Inclusion Criteria:\n\n* PARTICIPANTS RECRUITED FROM SURVEILLANCE, EPIDEMIOLOGY, AND END RESULTS PROGRAM (SEER)-GEORGIA: Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer), melanoma, or testicular cancer at any stage and reported to the SEER-Georgia registry\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: 2-10 years after diagnosis with cancer\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: English speaking (able to read and speak English)\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate \"not at all\" will be told the study is focused on those who experience worry)\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Residing in the United States\n* PARTICIPANTS RECRUITED FROM THYROID CANCER SURVIVORS' ASSOCIATION INC. (THYCA): Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment\n* PARTICIPANTS RECRUITED FROM THYCA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer) at any stage\n* PARTICIPANTS RECRUITED FROM THYCA: 2-10 years after diagnosis with cancer\n* PARTICIPANTS RECRUITED FROM THYCA: English speaking (able to read and speak English)\n* PARTICIPANTS RECRUITED FROM THYCA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate \"not at all\" will be told the study is focused on those who experience worry)\n* PARTICIPANTS RECRUITED FROM THYCA: Residing in the United States\n\nExclusion Criteria:\n\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects from certain vulnerable populations will be excluded as appropriate: fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)\n\n  * It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects that do not meet the inclusion criteria\n* PARTICIPANTS RECRUITED FROM THYCA: Subjects from certain vulnerable populations will be excluded as appropriate fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)\n\n  * It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman\n* PARTICIPANTS RECRUITED FROM THYCA: Subjects that do not meet the inclusion criteria","20 Years",{"count":424,"type":22},142,[25],"This pilot clinical trial is intended to compare the effect of a psychosocial support tool for young adult (YA)cancer survivors - including high-quality information about their cancer combined with evidence-based psychosocial support - to a support tool providing cancer-specific information alone (minus psychosocial modules). This tool, called Thrive Track, will be for YA patients aged 20-39 with thyroid, melanoma, or testicular cancer. Young adult survivors frequently experience persistent worry and distress that can interfere with coping and reduce quality of life. They are also particularly vulnerable to the emotional impact of cancer and may not have adequate support to manage these concerns. The enhanced version of Thrive Track includes personalized emotional support content and strategies designed to help patients better manage worry and distress. Adding these emotional support tools may provide greater benefit than survivorship education alone in strengthening young adult survivors' ability to manage their emotional well-being.",[428,429,430,431,432],"Differentiated Thyroid Gland Carcinoma","Malignant Testicular Neoplasm","Melanoma","Thyroid Gland Follicular Carcinoma","Thyroid Gland Papillary Carcinoma","2026-06-23",{"date":435,"type":34},"2026-06-24",{"date":437,"type":22},"2026-07",{"date":349,"type":22},{"name":40,"class":41},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":42},"100600222","phase-2-ivonescimab-before-surgery-for-the-treatment-of-resectable-stage-ii-iv-head-and-neck-cancer-100600222","NCT07094685","Ivonescimab Before Surgery for the Treatment of Resectable Stage II-IV Head and Neck Cancer","A Phase II Study Evaluating Neoadjuvant Ivonescimab for Resectable Head and Neck Cancer","SENIOR-HN","Inclusion Criteria:\n\n* At least 18 years of age\n* PD-L1 combined positive score (CPS) \\>= 1\n* Histologically documented advanced stage mucosal HNSCC (stage II-IV), for which surgery would be recommended in routine clinical practice\n* Primary tumor is amenable to fresh biopsy or availability of archival fresh frozen primary tissue\n* Eastern Cooperative Oncology Group (ECOG) 0-1\n* Absolute neutrophil count \\> 1500 cells\u002FuL\n* Platelet count \\>= 100,000\u002FuL\n* Hemoglobin \\>= 9.0 g\u002FdL (without transfusion within 14 days prior to cycle 1, day 1)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN for participants with Gilbert's disease\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x institutional ULN\n* Creatinine =\\\u003C 1.5 x institutional ULN OR estimated glomerular filtration rate (eGFR) value \\>= 30\u002FmL using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation OR measured (OR calculated) creatinine clearance \\>= 50 mL\u002Fmin using the Cockcroft-Gault Formula\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n* Prothrombin time (PT) or international normalized ratio (INR) =\\\u003C 1.5 x ULN, and partial thromboplastin time (PTT) or activated (a)PTT =\\\u003C 1.5 x ULN (unless abnormalities are unrelated to coagulopathy) This applies only to patients who are not on therapeutic anti-coagulation\n\n  * For patients receiving therapeutic anti-coagulation there are no coagulation parameters for eligibility. However, patients should be on a stable dose\n* Female patients of childbearing age per institutional definition must have negative serum pregnancy test results before enrollment\n* Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of ivonescimab\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n* Ability to understand and the willingness to sign a written informed consent\n* Deemed to be a candidate for trial therapy by University of Michigan providers in both Medical Oncology and Otolaryngology or Oral and Maxillofacial Surgery\n\nExclusion Criteria:\n\n* Prior radiation therapy for treatment of the current mucosal HNSCC (patients undergoing salvage resection are excluded)\n* Prior neck dissection on the side of current mucosal HNSCC\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment. Minor local procedures (excluding central venous catheterization, port implantation, and tumor biopsy) within 3 days prior to planned cycle 1, day 1\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment\n* Nasal bleeding \u002F epistaxis (bloody nasal discharge is allowed) graded as \\>= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 within 14 days prior to registration\n* Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as INR or aPTT is within therapeutic limits\n* Patients with a condition requiring corticosteroid therapy (\\> 10 mg prednisone\u002Fday or equivalent) within 14 days of the first dose of study drug. Exceptions: Physiologic replacement doses are allowed even if they are \\> 10 mg of prednisone\u002Fday or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder\n* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date. Exceptions: Patients with vitiligo, type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that has resolved, or psoriasis that does not require systemic treatment are permitted\n* Patients with symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis \\>= 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Recipient of a solid organ or allogeneic stem cell transplant\n* Patients with active hepatitis B (Patients with stable or declining levels of hepatitis B deoxyribonucleic acid \\[DNA\\] by polymerase chain reaction \\[PCR\\] on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrollment will not be excluded)\n* Patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV ribonucleic acid \\[RNA\\] levels above the lower limit of detection)\n* Known allergy or hypersensitivity to any component of the study drug or any excipients (histidine, histidine hydrochloride, sucrose, polysorbate 80 (II), and water for injection); known history of severe hypersensitivity to other monoclonal antibodies\n* Patient is breastfeeding or plans to breastfeed during study participation\n* Radiographic evidence of major blood vessel encasement with narrowing of the vessel that the investigator determines will pose a significantly increased risk of bleeding\n* Live vaccine or live attenuated vaccine received within 4 weeks prior to planned enrollment or scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Has pre-existing peripheral neuropathy that is \\>= grade 2 by CTCAE version 5\n* History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment\n* Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n* History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Participant has active cardiovascular disease including, but not limited to:\n\n  * Thromboembolism\n\n    * Medical history of any grade arterial thromboembolic event, grade 3 and above venous thromboembolic event (as specified in NCI CTCAE 5.0)\n  * Cardiovascular disease\n\n    * Any of the following within 12 months prior to enrollment:\n\n      * Myocardial infarction\n      * Unstable angina\n      * Unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease)\n      * Transient ischemic attack\n      * Cerebrovascular accident\n      * Hypertensive Crisis\n      * Hypertensive encephalopathy\n      * Coronary stent placement\n    * Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary\n  * Hypertension\n\n    * Uncontrolled (persistent) hypertension:\n\n      * Systolic blood pressure \\> 160 mmHg; diastolic blood pressure \\> 100 mmHg\n  * Heart failure\n\n    * Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF within 12 months prior\n* Participant has uncontrolled illness including, but not limited to:\n\n  * Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrollment (excluding antiviral therapy for hepatitis B or C)\n  * Uncontrolled diabetes\n  * Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy)\n  * Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements\n  * Active bleeding diathesis requiring anticoagulant or antiplatelet therapy",{"count":449,"type":22},28,[75],"This phase II trial tests how well ivonescimab before surgery works in treating patients with stage II-IV head and neck cancer that can be removed by surgery (resectable). Ivonescimab is a bispecific monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A bispecific monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).",[453,454,455,456,457],"Advanced Head and Neck Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","Stage II Head and Neck Cutaneous Squamous Cell Carcinoma","Stage III Head and Neck Cutaneous Squamous Cell Carcinoma","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma",{"date":408,"type":34},{"date":460,"type":34},"2025-11-18",{"date":462,"type":22},"2030-11-01",{"name":40,"class":41},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":329},"100533408","phase-1-gilteritinib-for-the-treatment-of-alk-nsclc-100533408","NCT06225427","Gilteritinib for the Treatment of ALK NSCLC","Phase I Study of Gilteritinib for ALK Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Stage IV (American Joint Committee on Cancer \\[AJCC\\] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion\n* Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC NOS (not otherwise specified)\n* The presence of an oncogenic ALK fusion established from any Clinical Laboratory Improvement Act (CLIA) certified laboratory\n* The patient must belong to one of the following treatment cohorts.\n\n  * Cohort 1: Prior 1st generation ALK tyrosine kinase inhibitor (TKI) (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002For lorlatinib\n  * Cohort 2: Prior 1st generation ALK TKI (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002For lorlatinib, and platinum-doublet chemotherapy\n  * Cohort 3: Prior 1st generation ALK TK (crizotinib) and\u002For prior 2nd generation TKI (ceritinib, brigatinib, alectinib) and\u002F or lorlatinib, platinum-doublet chemotherapy, and any other number of antineoplastic agents (including immunotherapy, standard or investigational)\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥ 1500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)\n* Measured or calculated creatinine clearance (CrCl) ≥ 50mL\u002Fmin (calculated per Cockcroft-Gault formula)\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (per institutional guidelines) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n* Albumin ≥ 2.5g\u002FdL\n* Female subject of childbearing potential should have a negative serum pregnancy test within 21 days of enrollment prior to receiving the first dose of study medication\n* Female subjects of childbearing potential must be willing to use a highly effective method of contraception for the course of the study, through 180 days after the last dose of study medication. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method\n* Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 4 months after the last dose of study therapy. Note: Abstinence is acceptable, if patient documents that this is their usual lifestyle or preferred contraception method\n* Ability to swallow pills orally and per investigator's assessment, do not have any significant issues limiting absorption of drug\n* Ability to understand and the willingness to sign a written informed consent\n* Measurable disease per RECIST v1.1 criteria assessed per screening imaging\n* If a cancerous lesion is easily and safely accessible, a pre-treatment biopsy of this lesion is strongly encouraged but NOT required prior to first dose of gilteritinib. Archival or fresh tissue biopsy may be used as long as it was obtained prior to cycle 1 day 1 (C1D1)\n* At least 7 days must have elapsed since last anti-neoplastic TKI, chemotherapy, immunotherapy, or investigational agent prior to the first dose of gilteritinib\n\nExclusion Criteria:\n\n* Received palliative radiation within 7 days of enrollment\n* Received prior therapy with a FLT3 inhibitor\n* Has a concurrent active malignancy receiving interventional therapy unless it is the investigator's opinion that the concurrent active malignancy will NOT significantly impact the survival of the patient (i.e. early stage breast cancer or prostate cancer on hormonal therapy, basal cell carcinoma awaiting Moh's or other surgery and the respective interventional therapy does NOT interact or interfere with gilteritinib.\n* Has known active and symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n  * Subjects with previously treated brain metastases may participate provided they are stable (clinically asymptomatic, and ≥ 2 weeks since completion of treatment) and are not using steroids for at least 7 days prior to enrollment. A repeat MRI brain is not necessary to document stability\n  * Patients with carcinomatous meningitis are excluded regardless of clinical stability\n* If a patient is found to have new\u002Fenlarging brain metastases on the screening MRI, the patient may be monitored closely and radiation could be delayed if the patient has no symptoms, there is no vasogenic edema, and there is no evidence of midline shift.\n\n  * If the patient is symptomatic, there is vasogenic edema, and\u002For there is midline shift, the patient will need to undergo treatment for these brain metastases and meet exclusion criteria #4 exception to treated brain metastases prior to enrollment. A new MRI brain is NOT required in this situation\n* Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment\n* Has Child-Pugh class C cirrhosis from any cause\n* Mean triplicate screening electrocardiogram (EKG) corrected QT (QTc) \\> 480 ms. (QTc Framingham will be used for heart rate \\>100 bpm)\n* Grade 3 or 4 NYHA (New York Heart Association) congestive heart failure, unless screening echocardiogram obtained prior to enrollment showed a LVEF (left ventricular ejection fraction) ≥ 45%\n* Surgery within 4 weeks prior to first study dose\n* Requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A\n* Requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the patient\n* Requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor, with the exception of drugs that are considered absolutely essential for the care of the patient\n* Active\u002Funtreated hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; patients with treated HBV and HCV are allowed as long as they meet the AST\u002FALT and bilirubin criteria\n* Known hypersensitivity to gilteritinib or any of the excipients\n* Active and clinically significant pancreatitis",{"count":21,"type":22},[99],"This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.",[475,476],"Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8",{"date":408,"type":34},{"date":479,"type":34},"2024-07-25",{"date":481,"type":22},"2027-05",{"name":40,"class":41},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":500,"locationsCount":501},"100489459","metastatic-leiomyosarcoma-biomarker-protocol-100489459","NCT05653388","Metastatic Leiomyosarcoma Biomarker Protocol","Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy","Inclusion Criteria:\n\n* Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement\n* Receiving first-line chemotherapy with doxorubicin- based or gemcitabine\u002Fdocetaxel\n* Target lesions per RECIST 1.1\n* Optional archival tumor tissue including 1 H\\&E-stained slide and unstained tumor tissue \\[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\\] available for study research",{"count":491,"type":22},200,"Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced\u002Fmetastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.",[385],[387,495,388],"Biomarker",{"date":435,"type":34},{"date":498,"type":34},"2022-12-22",{"date":131,"type":22},{"name":40,"class":41},11,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":42},"100621006","a-virtually-delivered-diet-intervention-laso-3-for-the-improvement-of-chemotherapy-induced-peripheral-neuropathy-in-cancer-survivors-post-treatment-100621006","NCT07365007","A Virtually Delivered Diet Intervention (LASO-3) for the Improvement of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors Post-treatment","Feasibility of a Virtually Delivered LASO-3 Diet Intervention for Chemotherapy-Induced Peripheral Neuropathy in Post-Treatment Cancer Survivors","Inclusion Criteria:\n\n* 18 years or older\n* At least three months since last receiving neurotoxic chemotherapy\n* Self-report moderate (≥ 2\u002F4) numbness and tingling on the Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE™) Numbness and Tingling Severity Item in the last week\n* Speak\u002Fread English\n* Have access to the internet\n\nExclusion Criteria:\n\n* Pre-existing peripheral neuropathy from any cause\n* Plan to begin a new prescription of duloxetine (i.e., first-line treatment for CIPN pain) during the study period\n* Are enrolled in symptom management trials that may alter CIPN severity\n* High grade inflammatory disease such as lupus, Crohn's disease, or rheumatoid arthritis\n* Routine nonsteroidal anti-inflammatory drug (NSAID) or steroid supplementation\n* Consuming an average three or more servings of fish per week and\u002For consuming fish oil capsules containing eicosapentaenoic acid (EPA)+ docosahexaenoic acid (DHA) daily or consuming flax oil capsules daily\n* Consuming an average of less than 5 servings of sweets, candy bars, chocolate, doughnuts, cookies, cakes, pie, brownies, ice cream, pastries, or sugar sweetened beverages (e.g., soda or coffee\u002Ftea) per week",{"count":73,"type":22},[25],"This clinical trial studies whether a virtually delivered diet intervention focused on lower added sugar, higher fiber, and higher omega 3 fatty acid (LASO-3) can be used to improve chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors after treatment. Cancer survivors often experience CIPN during and after cancer treatment with neurotoxic chemotherapy. CIPN is characterized by nerve damage from chemotherapy that leads to numbness, tingling, or pain in the hands or feet. However, there are few treatments to manage CIPN. Inflammation contributes to the development of CIPN and dietary patterns that have been demonstrated to improve diet quality and reduce inflammation in cancer survivors may be promising for use as a CIPN management strategy. The LASO-3 diet intervention consists of virtually delivered nutrition education sessions provided by a Registered Dietitian. The sessions focus on three dietary goals, informed by the United States Dietary Guidelines for Americans: 1) lowering added sugar intake to \\\u003C 10% of daily calories, 2) increasing daily fiber intake to ≥ 20 grams, and 3) increasing intake of moderate-high omega-3 seafood to three or more servings weekly or 3300-3400 mg\u002Fday of alpha-linolenic acid (e.g., plant-based sources include canola or flaxseed oil, walnuts, or flaxseed or chia seeds). The Registered Dietitian tailors the sessions to the patient based on information and feedback obtained throughout the sessions. The LASO-3 diet intervention may be an effective way to improve CIPN in cancer survivors after treatment.",[232,28,29],"2026-06-22",{"date":515,"type":34},"2026-06-25",{"date":517,"type":34},"2026-02-23",{"date":519,"type":22},"2028-03-01",{"name":40,"class":41},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":312,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":42},"100605092","phase-2-leuprolide-and-goserelin-for-ovarian-function-suppression-in-pre--or-peri-menopausal-women-with-breast-cancer-ofs-trial-100605092","NCT07158021","Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial","Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)","Inclusion Criteria:\n\n* Female subject aged ≥ 18 years\n* Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.\n* Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.\n* Not planning bilateral salpingo-oophorectomy during the 6-month study duration\n* Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4\u002F6 (CDK4\u002F6) inhibitor, and\u002For phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n\nExclusion Criteria:\n\n* Prior bilateral salpingo-oophorectomy\n* Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)\n* Concomitant use of systemic or transdermal estrogen products\n* Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications\n* Unable to take oral medications\n* Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen",{"count":529,"type":22},75,[75],"This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and\u002For effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.",[533,534,535,536,537],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","2026-06-18",{"date":433,"type":34},{"date":541,"type":34},"2026-01-22",{"date":543,"type":22},"2028-01-01",{"name":40,"class":41},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":552,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":42},"100587404","navigation-interventions-to-improve-cascade-genetic-testing-among-relatives-of-patients-with-hereditary-cancer-syndromes-100587404","NCT06927947","Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients With Hereditary Cancer Syndromes","Testing Effectiveness of Navigation Interventions to Increase Uptake of Cascade Genetic Testing Among Relatives of Individuals Diagnosed With Hereditary Cancer Syndromes","Inclusion Criteria:\n\n* PROBANDS: Clinically confirmed autosomal dominant pathogenic germline variant (PGV) associated with a hereditary cancer syndrome\n* PROBANDS: Previous evaluation by the University of Michigan (U-M) Cancer Genetics Clinic\n* PROBANDS: ≥ 18 years old\n* PROBANDS: Able to speak and read English\n* PROBANDS: Access to the internet\n* RELATIVES: Biological relative of proband\n* RELATIVES: ≥ 18 years old\n* RELATIVES: Able to speak and read English\n* RELATIVES: Access to the internet\n* RELATIVES: Have not completed germline genetic testing, per self-report at baseline\n\nExclusion Criteria:\n\n* RELATIVES: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline",true,{"count":554,"type":22},625,[25],"This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.",[558,559],"Hereditary Malignant Neoplasm","Hereditary Neoplastic Syndrome","2026-06-11",{"date":562,"type":34},"2026-06-15",{"date":564,"type":34},"2025-09-23",{"date":566,"type":22},"2026-09-30",{"name":40,"class":41},""]