[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abramson Cancer Center at Penn Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":596},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,40,63,86,111,140,167,191,213,239,257,288,310,329,352,371,395,422,445,464,491,512,532,553,574],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100265239","penn-surveillance-markers-of-utility-for-recurrence-after-neoadjuvant-therapy-for-breast-cancer-100265239",false,"NCT02732171","PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer","Inclusion Criteria:\n\n* Histologically-confirmed primary invasive breast cancer within 5 years of study entry\n* Qualifying risk status, at diagnosis utilizing receptor testing by ASCO\u002FCAP guidelines, meeting at least one of the following:\n\n  * Pathologically-confirmed invasive breast cancer in axillary lymph nodes, regardless of receptors\n  * Primary tumor with triple negative subtype: estrogen receptor (ER) \\\u003C 10%, progesterone receptor (PR) \\\u003C 10% and negative Her2-overexpression by ASCO-CAP guidelines\n  * Primary tumor that is ER+\u002FHer2 negative\u002FLymph node negative with a Breast Cancer Recurrence Score of ≥ 25 per the Genomic Health Oncotype DX breast cancer test and\u002For HighRisk MammaPrint\n  * Evidence of residual disease in the breast on pathologic assessment after neoadjuvant chemotherapy\n* Completed all primary therapy (surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and\u002For Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry. Concurrent receipt of adjuvant endocrine therapy and bone modifying agents is allowed per standard of care. However, tamoxifen is not allowed on recurrence prevention trials that use Hydroxychloroquine. Patients on tamoxifen may still be enrolled on Penn-Surmount as long as the treating physician is aware and tamoxifen can be stopped if patient is DTC positive.\n* No evidence of local or distant recurrent disease by physical examination, blood tests (CBC, LFTs, Alk Phos), or symptom-directed imaging, per NCCN guidelines.\n* Adequate bone marrow function as shown by: ANC \\>\u002F= 1.5x10\\^9\u002FL, Platelets \\>\u002F= 100x10\\^9\u002FL, Hb \\> 9 g\u002FdL\n* Adequate liver function as shown by: Serum bilirubin \\\u003C\u002F= 1.5 x ULN, ALT and AST \\\u003C\u002F= 2.5 x ULN, and INR \\\u003C\u002F= 1.5\n* Normal coagulation studies: PT and PTT ≤ 1.5 x upper limit of normal per institutional laboratory range\n* Anti-coagulation is allowed if target INR \\\u003C\u002F= 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \\>2 weeks at time of enrollment. For patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure (bone marrow aspirate) per standard clinical management.\n* Adequate renal function: serum creatinine \\\u003C\u002F= 1.5 x ULN\n* Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications\n* Age 18 or over and able to give informed consent\n\nExclusion Criteria:\n\n* Concurrent enrollment on another investigational therapy\n* Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone \\>50mg; hydrocortisone \\>40mg, prednisone \\>10mg, methylprednisone \\>8mg or dexamethasone \\>1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.\n* EKG demonstrating QTC \\> 480 ms\n* Patients who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study such as:\n\n  * History or evidence of increased cardiovascular risk including any of the following: (i) current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation, (ii) History of acute coronary syndromes (including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to enrollment, (iii) Current \\>\u002F= Class II congestive heart failure as defined by New York Heart Association\n  * History of pneumonitis\u002Finterstitial lung disease or severely impaired lung function with a previously documented spirometry and DLCO that is 50% of the normal predicted value and\u002For 02 saturation that is 88% or less at rest on room air\n  * Uncontrolled diabetes\n  * Active (acute or chronic) or uncontrolled severe infections\n  * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis\n  * A known history of HIV seropositivity as reported by the patient\n  * History of major surgical resection involving the stomach or small bowel, or pre-existing impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, Crohn's disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)\n  * Patients with an active, bleeding diathesis\n  * History of retinopathy or retinal vein occlusion\n* Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative urine or serum pregnancy test.\n* Patients who have received prior treatment with a CDK4\u002F6 inhibitor\n* Patients with a known hypersensitivity to Hydroxychloroquine or any of its derivatives\n* Patients with prior hydroxychloroquine exposure for a duration of \\> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and\u002For Her2-directed therapy) for the index malignancy\n* Patients who have initiated bone modifying agents within 3 months prior to study enrollment\n* A detailed assessment of Hepatitis B\u002FC medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and\u002For confirmation of prior HBV\u002FHCV infection.","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse.\n\nPatients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).",[26],"Breast Cancer","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-19","ACTUAL",{"date":33,"type":4},"2016-04",{"date":35,"type":20},"2030-04",{"name":37,"class":38},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100495631","early-phase-1-neoadjuvant-pembrolizumab-and-lenvatinib-for-renal-cell-carcinoma-100495631","NCT05733715","Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma","Randomized Pilot Clinical Trial of Neoadjuvant Pembrolizumab +\u002F- Lenvatinib for High Risk Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of renal cell carcinoma will be enrolled in this study.\n2. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of lenvatinib:\n\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause o Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of child-bearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n3. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a WOCBP OR\n   * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Histologically or cytologically confirmed diagnosis of renal cell carcinoma based on newly obtained renal mass core biopsy performed during study screening procedures.\n6. Renal cell carcinoma with clinical stage cT2 to cT4 based on screening CT or MRI imaging assessment and eligible for surgical resection.\n\n   Note: Patients with regional nodal involvement (cN+) may be included irrespective of clinical T stage, provided disease is deemed \"resectable\" per treating urologic surgeon.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n8. Have adequately controlled BP with or without antihypertensive medications, defined as BP ≤150\u002F90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization.\n9. Have adequate organ function.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 24 hours prior to first dose of lenvatinib (ARM A only) or within 72 hours prior to first dose of pembrolizumab (ARMS A and B) (see Appendix 3).\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n4. Has had major surgery within 3 weeks prior to first dose of study interventions.\n5. Has evidence of distant metastatic disease on CT\u002FMRI scans Note: Regional nodal metastases and\u002For ipsilateral adrenal metastasis are acceptable, if deemed resectable per primary urologic surgeon.\n6. Has a need for urgent surgical resection per treating investigator\n7. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n8. Has a LVEF ≤40%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n9. Subjects having \\> 1+ proteinuria on urine dipstick testing, unless a 25-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n10. Prolongation of QTcF interval to \\>480 ms.\n11. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n12. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib per investigator discretion\n13. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n14. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n17. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive urothelial carcinoma, low- or intermediate-risk prostate cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n18. Has severe hypersensitivity (≥Grade 3) to pembrolizumab or lenvatinib and\u002For any of their excipients.\n19. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n20. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. Has an active infection requiring systemic therapy.\n22. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n23. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n24. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n25. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n26. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n27. Has had an allogenic tissue\u002Fsolid organ transplant.",true,{"count":49,"type":20},30,[51],"EARLY_PHASE1","This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.",[54],"Renal Cell Carcinoma","2026-08-11",{"date":57,"type":31},"2026-08-13",{"date":59,"type":31},"2023-05-03",{"date":61,"type":20},"2028-12",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":16,"minAge":70,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":39},"100337994","frailty-phenotype-assessments-to-optimize-treatment-strategies-for-older-patients-with-hematologic-malignancies-100337994","NCT03680677","Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","Eligibility Criteria Arm A:\n\n* Age 60 years or older.\n* New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.\n* Able to consent to the study.\n\nEligibility Criteria Arm B:\n\n* Age 60 years or older with a hematologic malignancy.\n* Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.\n* Able to consent to the study.","60 Years",{"count":72,"type":20},20,"OBSERVATIONAL","The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.",[76,77],"Leukemia, Acute","MDS","2026-08-10",{"date":80,"type":31},"2026-08-12",{"date":82,"type":31},"2018-09-21",{"date":84,"type":20},"2027-11",{"name":37,"class":38},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100445904","wbsi-guided-personalized-delivery-of-ttfields-100445904","NCT05086497","WBSI Guided Personalized Delivery of TTFields","Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields","Inclusion Criteria:\n\n* Adult population ≥ 22 years\n* Histologically confirmed diagnosis of GBM or molecular GBM according to c-IMPACT NOW criteria\n* Have undergone maximal safe surgical resection followed by either standard full course radiation of 6000 cGy in 6 weeks or a hypofractionated course of 4000 cGy in 3 weeks\n* 3 Harboring any genotype profiles (MGMT promoter methylation or unmethylation and\u002For isocitrate dehydrogenase (IDH) mutant or IDH wild-type)\n* Possessing adequate hematological, hepatic and renal functions\n* Willingness to receive TTFields\n\nExclusion Criteria:\n\n* Presence of infra-tentorial GBM\n* Pregnancy\n* Significant co-morbidities at baseline which would prevent maintenance TMZ treatment\n* Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators,pacemakers, defibrillators and programmable shunts. , other implanted electronic devices in the brain.\n* Sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.\n* Presence of significant hemorrhage in and around the tumor bed that may potentially degrade the image quality.","22 Years",{"count":95,"type":20},155,[23],"This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with \"standard array mapping\" (based on regular contrast enhanced MRI) or an \"alternative (more precise) array mapping\" based on sophisticated state of the art MRI techniques including \"whole brain spectroscopy\". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.",[99,100,101],"GBM","Glioma Glioblastoma Multiforme","Tumor, Brain","2026-08-05",{"date":104,"type":31},"2026-08-06",{"date":106,"type":31},"2023-01-15",{"date":108,"type":20},"2027-06-30",{"name":37,"class":38},2,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":16,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100582999","practical-geriatric-assessment-pga-implementation-strategies-and-correlative-evaluations-pace-70-100582999","NCT06870617","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70)","Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations for Older Adults With Cancer (PACE-70): A Hybrid Implementation-effectiveness Study","PACE-70","For PGA Implementation Cohort, patients must meet the following criteria:\n\n1. Age greater than or equal to 70 years.\n2. Diagnosis of advanced or metastatic solid malignancy\n3. Initiating a new line of palliative-intent systemic therapy with a prevalence of grade 3 toxicity exceeding 50%.\n\nFor Correlative Analysis Cohort, patients must additionally meet the following criteria:\n\n1. Must read and speak English and be able to fill out surveys\n2. Ability to walk independently or with the use of an assistive device (e.g., walker, cane)\n3. Consents to participate in correlative analysis cohort with Fitbit monitoring, body composition analysis, and self-report surveys\n4. Have a smartphone able to operate with the Fitbit\n\nFor PGA Implementation Cohort, there are no specific exclusion criteria other than not meeting inclusion criteria.\n\nFor Correlative Analysis Cohort, patients will be excluded if meeting any of the following criteria:\n\n1. Unable to effectively read and speak English\n2. Reliance on a wheelchair, ECOG of 3 or above, clinically bedbound, or unable to walk without assistance every day for the past 7 days (ECOG 3 is confined to bed or chair for more than 50% of waking hours)\n3. Concurrent enrollment in a therapeutic clinical trial (as clinical trials often have a substantial symptom-reporting structure). Non-therapeutic clinical trial enrollment is permitted\n4. Lack of clinician consent to approach patient","70 Years",{"count":121,"type":20},150,"The use of a geriatric assessment to inform oncologic care for older persons with cancer is an evidence-based practice that improves patient-clinician communication, reduces treatment-related toxicity, and is recommended by national guidelines. However, the implementation of a geriatric assessment can be time-consuming and burdensome, leading to suboptimal use in clinical practice. Developed and endorsed by the American Society for Clinical Oncology (ASCO), the Practical Geriatric Assessment (PGA) is designed to improve clinical usability and adoption, but its implementation in real-world settings has not been evaluated. The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a community setting. An exploratory aim will evaluate how the PGA, body composition (via abdominal computed tomography scan) and step count monitoring (via FitBit) correlate with chemotherapy toxicity and other clinical outcomes.",[124,125,126],"Geriatric Assessment","Advanced Cancer","Toxicity",[117,128,129,130,131],"Practical geriatric assessment","body composition in cancer","step count in cancer","Start low go slow","2026-08-04",{"date":104,"type":31},{"date":135,"type":31},"2025-07-01",{"date":137,"type":20},"2026-10-01",{"name":37,"class":38},3,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":147,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":139},"100512414","strategies-to-close-the-gap-from-cervical-cancer-diagnosis-to-treatment-in-botswana-100512414","NCT05952141","Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Inclusion Criteria:\n\nPatients will be eligible if they:\n\n1. are biological females\n2. are aged 18 or older\n3. have pathology-confirmed invasive cervical cancer diagnosis\n4. have pathology results evaluated at National Health Laboratory in Botswana\n5. are citizens of Botswana\n6. have no prior history of invasive cervical cancer\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n1. are biological males or otherwise born without a cervix\n2. are below the age of 18 due to the rarity of cervical cancer in this population\n3. do not meet study inclusion criteria","FEMALE",{"count":149,"type":20},610,[23],"Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.",[153],"Cervical Cancer",[155,156,157,158],"Screening","Botswana","Treatment","Patient","2026-07-21",{"date":161,"type":31},"2026-07-22",{"date":163,"type":31},"2023-09-01",{"date":165,"type":20},"2027-08-31",{"name":37,"class":38},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":110},"100647818","low-dose-radiotherapy-for-osteoarthritis-100647818","NCT07715188","Low Dose Radiotherapy for Osteoarthritis","A Prospective Study of Low Dose Radiotherapy for Osteoarthritis","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosis of OA \\>3 months in hips, knees, hands, shoulders, ankles or elbows.\n* Refractory to standard of care therapies for OA or those who are being considered for more aggressive interventional treatment such as joint replacement, but more conservative treatment is desired.\n* Provision of signed and dated informed consent.\n\nExclusion Criteria:\n\n* Unable to reasonably complete study instruments.",{"count":175,"type":20},113,[23],"This single institution, multi-site, single arm prospective study will enroll patients with a history of OA and assess changes in pain and function after treatment with LDRT as measured by patient-reported outcomes.",[179],"Osteoarthitis",[181,182],"Low Dose Radiotherapy","Osteoarthritis","2026-07-15",{"date":185,"type":31},"2026-07-20",{"date":187,"type":31},"2026-06-24",{"date":189,"type":20},"2029-06",{"name":37,"class":38},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":39},"100645967","early-phase-1-picstat-pilot-study-for-cd8-petct-guided-lifileucel-treatment-in-advanced-melanoma-100645967","NCT07700121","PICSTAT Pilot Study for CD8 PET\u002FCT-Guided Lifileucel Treatment in Advanced Melanoma","PICSTAT (PET Imaging of CD8 for Selection of Tumors for Autologous TIL): A Pilot Study Assessing the Use of CD8 PET\u002FCT (Zr-89 Crefmirlimab Berdoxam) to Enhance Lifileucel (AMTAGVI) Efficacy in Patients With Treatment Refractory Stage IV Melanoma","PICSTAT","Inclusion Criteria:\n\n* Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV)\n* Participants must have progressed following ≥ 1 prior systemic therapy for Stage IV or unresectable Stage III disease including a PD- 1 blocking antibody; and if BRAF V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor.\n* At least two resectable previously non-irradiated lesions (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post- resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)\n* Lesions in the spleen should not be selected as resectable lesions, because they are not well evaluated by CD8 PET\u002FCT imaging due to high background signal in that organ\n* In addition to the two resectable lesions, at least one measurable target lesion, as defined by RECIST v1.1\n\n  1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion\n  2. If a lesion is partially resected to generate TIL, and remains visible on the Baseline scan after surgery, then the partially resected lesion can be used for RECIST v1.1 response assessment, but only as a non- target lesion\n* Participants must be ≥ 18 years of age at the time of consent.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .\n* Participants must have signed informed consent for the PICSTAT companion CD8 PET imaging protocol.\n* Participants are eligible for treatment with AMTAGVI per the recommendation of the treating oncologist.\n* Participant (or legally authorized representative) is capable of giving signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Participants of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the protocol and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy\n* Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 6.0.\n\nExclusion Criteria:\n\n* Participants who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Participant has melanoma of uveal\u002Focular origin.\n* Participants who have a history of hypersensitivity to any component or excipient of lifileucel (AMTAGVI) or other study drugs: a. Hypersensitivity to PET tracer b. LD chemo regimen (cyclophosphamide, mesna, and fludarabine) c. Proleukin®, aldesleukin, IL-2 d. Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); (These participants may be eligible if current hypersensitivity has been excluded.) e. Any component of the lifileucel infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Participant has symptomatic untreated brain metastases. Participants with brain metastases may be considered for study participation with the following considerations and only after discussion with the Investigator:\n\n  1. Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.\n  2. A participant with historically treated brain metastases (i.e., treatment was completed \\>28 days prior to consenting for study participation) may be considered for study participation if the participant is clinically stable for ≥ 2 weeks, there are no new or worsening brain lesions via screening CT or MRI, and the participant does not require ongoing corticosteroid treatment (\\>10 mg\u002Fday prednisone or equivalent).\n  3. If there are progressive or new brain metastases on the screening CT or MRI, the participant should first receive treatment for them prior to restarting or continuing screening. A participant with recently treated brain metastases (i.e., treatment of brain metastases was completed ≤ 28 days prior to consenting for study participation) may be considered for study participation if the participant is asymptomatic, clinically stable for ≥ 2 weeks, and does not require corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) by the end of the screening period. Repeat brain imaging is not required after treatment.\n* Participant requires systemic steroid therapy \\> 10 mg\u002Fday of prednisone or another steroid equivalent dose.\n\nParticipants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg\u002Fday of prednisone or another steroid equivalent dose may be eligible\n\n* Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening\n* Participants who are pregnant or breastfeeding.\n* Participants who have active medical illness(es) that would pose increased risk for study participation, including: active uncontrolled infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of LD chemo regimen.",{"count":200,"type":20},10,[51],"This prospective, single-center pilot study is being performed to find out whether Zr-89 crefmirlimab berdoxam \"CD8 PET\u002FCT\" scans can improve the effectiveness of the tumor-infiltrating lymphocyte (TIL) therapy called lifileucel (\"Study Treatment\") in treating metastatic melanoma.\n\nParticipants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.",[204],"Unresectable or Metastatic Melanoma","NOT_YET_RECRUITING","2026-07-07",{"date":208,"type":31},"2026-07-13",{"date":137,"type":20},{"date":211,"type":20},"2029-10-01",{"name":37,"class":38},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":4},"100639699","phase-1-combining-neo-adjuvant-atr-inhibition-with-nodal-sbrt-for-early-stage-resectable-hpv-opsccs-100639699","NCT07578467","Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","A Phase Ib\u002FII Study Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs","Inclusion Criteria:\n\n* Age ≥ 18\n* Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy.\n* Patients' blood calcium level is within a safe range\n* Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results\n* If a participant is female, she must not be pregnant or breastfeeding.\n* If a participant is male, he must agree to use highly effective birth control from the start of the study until a short period after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients with late-stage tumors (Stage III or IV)\n* If the cancer has already spread to distant parts of the body (M1) when first diagnosed\n* Prior advanced head and neck cancer requiring radiation or major surgery\n* Patients whose original tumor site cannot be identified\n* Patients that have a known additional malignancy that is progressing or requires active treatment\n* Patients that had a surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. This does not include procedures that are used to diagnose or determine extent of study disease (such as biopsies).\n* Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment.\n* Patients with active infections and\u002For receiving systemic antibiotics or anti-viral medications.\n* Patients with uncontrolled HIV or active hepatitis B or C are usually not eligible. However, those whose infections are well-controlled on treatment for at least a month and meet certain viral load limits can participate\n* Current or past diagnosis of leukemia within the past 5 years.\n* Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.\n* Patient has uncontrolled hypertension at time of enrollment.\n* Patients who recently had serious kidney problems or kidney disease.\n* Patients cannot have taken another experimental drug within 30 days-or within a period equal to five times that drug's half-life-before starting this study\n* Medical illness that, in the opinion of the Investigator, may impact the safety of the patient\n* Patients who use recreational drugs or have mental health conditions that might make it hard to follow study visits, based on the doctor's judgment.\n* Known hypersensitivity to ATRN-119 or its ingredients\n* Patients with serious liver disease or liver problems that could affect how the body processes the study drug\n* Patients who are fairly limited in daily activities (ECOG score of 2 or higher)\n* Patients with serious other health problems that the doctor thinks could prevent them from completing the study\n* Pregnancy or lactation\n* Inability to provide informed consent",{"count":221,"type":20},35,[223,224],"PHASE1","PHASE2","This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.\n\nThe goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.\n\nParticipants will:\n\n* Take 800mg of ATRN-119 every day for 10 days\n* Receive 1 treatment (called a \"fraction\") of SBRT to the neck on day 3 of ATRN-119 dosing.\n* Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team\n* Receive standard of care treatment after treatment with ATRN-119 + SBRT including TransOral Robotic Surgery (TORS) to remove the primary tumor with Neck Dissection and adjuvant therapy (if indicated)\n* Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment",[227,228,229,230,231],"HPV Positive Oropharyngeal Squamous Cell Carcinoma","Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV Associated Cancers","Oropharyngeal HPV Squamous Cell Carcinoma",{"date":233,"type":31},"2026-07-08",{"date":235,"type":20},"2026-08-31",{"date":237,"type":20},"2030-08-31",{"name":37,"class":38},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100558438","quantifyher-quantitative-immunofluorescence-andor-rt-qpcr-for-measuring-her2-in-her2-low-metastatic-breast-cancer-100558438","NCT06551116","QuantifyHER: Quantitative Immunofluorescence and\u002For RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer","Inclusion Criteria:\n\n* Women and men age \\> 18 years\n* Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO\u002FCAP guidelines.\n* Primary and\u002For metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO\u002FCAP guidelines.\n* Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible.\n* Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible.\n* Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation.\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO\u002FCAP guidelines)",{"count":246,"type":20},200,"This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.",[249],"HER2-positive Metastatic Breast Cancer",{"date":233,"type":31},{"date":252,"type":31},"2024-10-10",{"date":254,"type":20},"2029-09-01",{"name":37,"class":38},37,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":274,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":39},"100629759","phase-1-radiation-oral-vancomycin-and-car-t-for-b-cell-lymphomas-100629759","NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures",{"count":265,"type":20},14,[223],"This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[269,270,271,272,273],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[275,276,277,278,279],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","2026-06-29",{"date":282,"type":31},"2026-07-01",{"date":284,"type":31},"2026-05-29",{"date":286,"type":20},"2029-01-01",{"name":37,"class":38},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":295,"minAge":17,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":39},"100457909","ftt-petct-in-metastatic-prostate-cancer-100457909","NCT05242744","FTT PET\u002FCT in Metastatic Prostate Cancer","Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET\u002FCT) in Patients With Metastatic Prostate Cancer","Inclusion Criteria:\n\n1. Participants will be ≥ 18 years of age\n2. Histologically proven prostate carcinoma\n3. Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET\u002FCT, Ultrasound)\n4. Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and\u002For androgen deprivation therapy (ADT) and\u002For chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.\n5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study","MALE",{"count":49,"type":20},"Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET\u002FCT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.",[299],"Prostate Cancer Metastatic",[301,302],"PET\u002FCT","PARP inhibitor",{"date":304,"type":31},"2026-06-26",{"date":306,"type":31},"2023-03-01",{"date":308,"type":20},"2027-07",{"name":37,"class":38},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":147,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":39},"100641461","a-mixed-methods-metabolomics-investigation-of-lifestyle-and-energy-balance-during-breast-cancer-survivorship-100641461","NCT07655934","A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship","The MILES Study: A Mixed-Methods Metabolomics Investigation of Lifestyle and Energy Balance During Breast Cancer Survivorship","MILES","Inclusion Criteria:\n\n* Adult women (age 18 years or older)\n* Able to read English or Spanish\n* Newly diagnosed with primary stage 0, I, II, or III breast cancer\n* Pathological diagnosis within the previous 60 days\n* Scheduled to have surgery with a Penn Medicine surgeon\n\nExclusion Criteria:\n\n* Women age less than 18 years\n* Women without a new primary breast cancer diagnosis\n* Women who are pregnant",{"count":319,"type":20},100,[23],"The MILES Study is a longitudinal, mixed-methods investigation of urinary biomarkers, energy balance, and lifestyle modifications in diverse women during early breast cancer treatment. The study's overarching goal is to assess dietary quality and physical activity changes over time using reliable, scalable tools suitable for clinical or population settings, supporting newly diagnosed patients in adopting and maintaining healthy behaviors through treatment and survivorship.",[26],"2026-06-22",{"date":187,"type":31},{"date":326,"type":31},"2026-01-20",{"date":61,"type":20},{"name":37,"class":38},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":110},"100580452","photobiomodulation-in-head-and-neck-cancer-related-chronic-lymphedema-100580452","NCT06837480","Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema","Placebo-Controlled Phase II Randomized Clinical Trial of Photobiomodulation Therapy in Head and Neck Cancer Survivors With Chronic Lymphedema","Inclusion Criteria:\n\n\\>18 years of age Biopsy proven head and neck cancer No evidence of cancer at the time of study enrollment, between 12- and 60-month post-cancer treatment Chronic lymphedema (defined as lymphedema persisting for a minimum of 6 months) A minimum of 2 sites of external lymphedema At least 1 site with lymphedema of moderate severity as assessed using the HN-LEF Assessment Criteria Failed lymphedema therapy (defined as any of the following: incomplete response to therapy, progression of lymphedema after therapy, inability to perform effective self-care resulting in fluid re-accumulation; and inability to complete treatment due to systems barriers). In addition, patients must be able to understand English in order to complete questionnaires; and to provide informed consent.\n\nExclusion Criteria:\n\nPatients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of PBMT:\n\nWomen of childbearing age and potential Acute cellulitis within the soft tissues in the head and neck region Chronic inflammatory diseases Venous thrombosis Carotid artery stenosis Requiring ongoing use of diuretics and corticosteroids Pre-existing skin rash, ulceration, open wound in the treatment area Active lymphedema or physical therapy (including hyperbaric oxygen or trental) Allergic and other systemic skin diseases",{"count":121,"type":20},[23],"The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.",[340,341],"Head and Neck Cancer","Lymphedema of the Head and Neck",[343],"Head and neck cancer, chronic lymphedema, photobiomodulation","2026-06-19",{"date":346,"type":31},"2026-06-23",{"date":348,"type":31},"2026-01-15",{"date":350,"type":20},"2029-11-30",{"name":37,"class":38},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":39},"100575328","consolidative-metastasis-and-primary-directed-therapy-mpdt-for-renal-cell-carcinoma-rcc-100575328","NCT06770855","Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)","A Phase II Study of Total Consolidative Metastasis-and-primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC).","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component)\n* Metastatic clear cell RCC with 5 or fewer metastases at enrollment (excluding pulmonary nodules \\\u003C1.0cm)\n* Stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy.\n* Has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists).\n* ECOG performance status \\\u003C 2\n* Must have archival tissue (slide or Formalin-Fixed Paraffin-Embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation\n* Consolidation surgery and biopsies are strongly encouraged to be within 42 days +\u002F- 7 days of holding systemic therapy.\n\nExclusion Criteria:\n\n* Subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator.\n* Subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). Stable spinal metastases resected and\u002For treated with SBRT in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate.\n* Any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded\u002Fdiscontinued from the trial in the event of a positive or borderline positive serum pregnancy test result.",{"count":360,"type":20},23,[23],"This is a non-randomized, open-label phase II study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (MPDT) among patients with partial response\u002Fstable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell RCC. The investigators hypothesize that patients who undergo total consolidative MPDT followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%",[54],"2026-06-18",{"date":346,"type":31},{"date":367,"type":20},"2026-06-30",{"date":369,"type":20},"2028-09",{"name":37,"class":38},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":16,"minAge":378,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100641743","early-phase-1-pilot-study-of-tumorglow-for-intraoperative-molecular-imaging-of-sarcoma-metastases-to-the-lungs-in-pediatric-patients-100641743","NCT07658768","Pilot Study of TumorGlow for Intraoperative Molecular Imaging of Sarcoma Metastases to the Lungs in Pediatric Patients","TumorGlow","Inclusion Criteria:\n\n* 1\\. Male and female children (12 - 17 years of age) with a primary diagnosis, or a high clinical suspicion of a solid tumor with metastasis to the lung warranting surgery based on CT\u002FPET or other imaging 2. Are scheduled to undergo surgical resection for suspected metastasis 3. Female subjects of childbearing potential (including those less than 2 years postmenopausal) agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG. Male subjects who are are sexually active (and capable of producing sperm) with a partner that could become pregnant, must agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after infusion of ICG.\n\nExclusion Criteria:\n\n* 1\\. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. History of anaphylactic reactions to ICG. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation 3. A positive serum pregnancy test at screening for female subjects of childbearing potential. Note that subjects with a positive pregnancy test on the day of infusion will be discontinued from study and will not receive the study drug.\n\n  4\\. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule 5. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin except in subjects with Gilbert's syndrome. \\*For subjects with Gilbert's syndrome, total bilirubin levels exceeding 3 mg\u002FdL will be excluded.\\* 6. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug 7. History of uncontrolled hypertension. (e.g., history of an emergency room \\[ER\\] admission for hypertensive crisis or ≥ 3 BP medications) 8. Known sensitivity to fluorescent light","12 Years","17 Years",{"count":72,"type":20},[51],"Subjects will undergo infusion of 5 mg\u002Fkg indocyanine green, ICG (\"TumorGlow\") intravenously up to 5-days prior to surgery. Then, during the surgical procedure the next day, the subjects will undergo standard-of-care surgery. During the surgery, the fluorescence from the tumor will be used to localize lesions and ensure the entire tumor has been removed, as well as locate any un-expected tumors. The goal of this protocol is to evaluate safety and collect initial efficacy data using indocyanine green with NIR fluorescence imaging in a pediatric patient population undergoing pulmonary metastatectomy.",[384],"Sarcoma Metastatic",[386,387],"metastasis","sarcoma","2026-06-17",{"date":323,"type":31},{"date":391,"type":20},"2026-09-01",{"date":393,"type":20},"2027-05-01",{"name":37,"class":38},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":405,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":39},"100603173","phase-4-allergy-delabeling-in-antibiotic-stewardship---intervention-100603173","NCT07133074","Allergy Delabeling in Antibiotic Stewardship - Intervention","Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention","RENEW-IN","Inclusion Criteria:\n\n* all patients with a hematologic malignancy (including Hodgkin and non-Hodgkin lymphoma, leukemia, and myeloma) admitted to an inpatient oncology service\n* reported history of a beta-lactam (BL) allergy (i.e., penicillin, cephalosporin, and\u002For carbapenem)\n\nExclusion Criteria:\n\n* patients with a history of severe cutaneous adverse reaction\n* patients with a history of Stevens-Johnson syndrome\n* patients with a history of toxic epidermal necrolysis\n* patients with a history of drug-induced exfoliative dermatitis\n* patients with a history of drug reaction with eosinophilia and systemic symptoms\n* patients with a history of acute generalized exanthematous pustulosis",{"count":404,"type":20},3800,[406],"PHASE4","The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.",[409,410],"Beta Lactam Allergy","Hematologic Malignancy",[412,413,414],"penicillin allergy","hematologic cancer","allergy delabeling","2026-06-15",{"date":388,"type":31},{"date":418,"type":31},"2026-04-20",{"date":420,"type":20},"2029-11",{"name":37,"class":38},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":431,"conditions":432,"keywords":435,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":39},"100495097","qol-and-sarcopenia-in-patients-with-ascites-100495097","NCT05726747","QOL and Sarcopenia in Patients With Ascites","Health-related Quality of Life Outcomes and Changes in Sarcopenia in Patients With Refractory Ascites","Inclusion Criteria:\n\n1. Age \\>\u002F=18\n2. Eastern Cooperative Oncology Group (ECOG) performance score \\\u003C 3\n3. Refractory ascites due to cirrhosis or malignancy, requiring more than 1 therapeutic paracentesis in a 6 week period within 3 months of enrollment.\n4. Capable of giving informed consent\n\nExclusion Criteria:\n\n1. Life expectancy less than 3 months\n2. Unable to participate in neuropsychological tests\u002Fquestionnaires\n3. Pregnant or nursing women. .",{"count":430,"type":20},70,"Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies.\n\nSarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites.\n\nProspectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.",[433,434],"Ascites Hepatic","Ascites, Malignant",[436,437],"ascites","sarcopenia","2026-06-12",{"date":415,"type":31},{"date":441,"type":31},"2023-05-23",{"date":443,"type":20},"2027-10",{"name":37,"class":38},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":147,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":39},"100627889","engaging-m-health-for-symptom-monitoring-and-health-promotion-for-women-on-endocrine-therapy-for-breast-cancer-emshape-100627889","NCT07454499","Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)","Inclusion Criteria:\n\n* Participants must identify as a woman\n* Participants must be age 18 or older\n* Participants must have a diagnosis of Stage 0, I, II, or III HR+ breast cancer\n* Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole) within 16 weeks of study registration.\n* Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization.\n* Participants who received chemotherapy must have finished it at least 14 days prior to randomization.\n* Speak and read in English\n* Own an internet-enabled cell phone\n* Capable of using the electronic pill bottle\n* Concomitant radiotherapy is allowed. Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, osteoclast inhibitor therapy, CDK 4\u002F6 inhibitor, ovarian function suppression medications) is allowed.\n\nExclusion Criteria:\n\n* Metastatic (Stage IV) breast cancer\n* Male gender\n* Prior treatment with endocrine therapy for breast cancer\n* Communication difficulties such as: Uncorrected or uncompensated hearing and\u002For vision impairment, uncorrected or uncompensated speech defects, uncontrolled psychiatric\u002Fmental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks",{"count":452,"type":20},60,[23],"The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.",[456],"Cancer","2026-06-10",{"date":438,"type":31},{"date":460,"type":31},"2026-05-13",{"date":462,"type":20},"2027-12-31",{"name":37,"class":38},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":47,"sex":16,"minAge":470,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":21,"phases":473,"briefSummary":474,"conditions":475,"keywords":479,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":39},"100608281","catalyzing-cigarette-smoking-cessation-through-harm-reduction-sampling-among-people-unmotivated-to-quit-100608281","NCT07199517","Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit","Inclusion Criteria:\n\n1. Able to communicate fluently in English (i.e., speaking, writing, and reading)\n2. Male and female smokers who are \\> 21 years of age and self-report smoking at least 5 cigarettes (menthol and\u002For non-menthol) per day for at least the last 6 months.\n3. Have a carbon monoxide (CO) greater than or equal to 10 ppm\n4. Not using any forms of nicotine regularly other than cigarettes.\n5. Not interested in quitting smoking in the next 30 days.\n6. Capable of giving written informed consent, including compliance with the requirements and restrictions listed in the combined consent and HIPAA form\n\nExclusion Criteria:\n\nSmoking Behavior\n\n1. Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.).\n2. Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.\n3. Current use of smoking cessation medication.\n4. Provide a CO breath test reading less than 10 ppm at Intake.\n\nAlcohol and Drug\n\n1. History of substance abuse (other than nicotine dependence) in the past 12 months.\n2. Current alcohol consumption that exceeds 20 standard drinks\u002Fweek.\n3. Current use of recreational drugs (other than nicotine and cannabis)\n\nMedical\n\n1. Women, including all individuals assigned as \"female\" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.\n2. Serious or unstable disease within the past year (e.g. cancer, uncontrolled hypertension, cardiovascular event).\n\nPsychiatric\n\n1\\. Lifetime history of schizophrenia or psychosis.\n\nGeneral Exclusion\n\n1. Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and\u002For the study design as determined by the Principal Investigator.\n2. Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.\n3. Significant non-compliance with protocol and\u002For study design as determined by the Principal Investigator and\u002Fo. Subjects may be deemed ineligible at any point throughout the study.","21 Years",{"count":472,"type":20},472,[23],"This study aims to investigate harm-reduction sampling in a choice format versus medicinal nicotine sampling on smoking behavior, identify mechanisms of sampling's effects, and explore moderators of these effects among a national sample of people unmotivated to quit smoking. Participants will be randomized 2:1 to choose one of two harm-reduction products (ECIG, ONP) versus a medicinal nicotine control condition (nicotine patch + lozenge, NPL), receive a 4-week starter product regimen, and then be followed for 6 months to assess use behavior.",[476,477,478],"Cigarette Smoking","Tobacco Use","Cigarette Smoking Behavior",[480,481,482,483],"cigarette smoking","harm reduction","sampling","nicotine replacement",{"date":485,"type":31},"2026-06-11",{"date":487,"type":31},"2026-01-12",{"date":489,"type":20},"2030-07-31",{"name":37,"class":38},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":147,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":21,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":139},"100497549","phase-2-proton-therapy-for-post-surgical-treatment-of-gynecologic-cancer-100497549","NCT05758688","PROton Therapy for Post Surgical Treatment of GYNecologic Cancer","Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers","PROPS GYN","Inclusion Criteria:\n\n* Histologically confirmed cervical or endometrial cancer\n* Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy\n* Age of 18 years or older\n* Written informed consent\n* ECOG of 0-2 within 3 months of enrolling\n\nExclusion Criteria:\n\n* Prior course of pelvic radiation\n* Metastatic disease outside of the pelvis\n* Active inflammatory bowel disease\n* Incapacity to provide informed consent",{"count":7,"type":20},[224],"This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.",[153,503,504],"Uterine Cancer","Endometrial Cancer","2026-06-09",{"date":457,"type":31},{"date":508,"type":31},"2023-11-06",{"date":510,"type":20},"2026-12",{"name":37,"class":38},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":21,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":39},"100388022","phase-2-carboplatin-taxane-and-ramucirumab-for-patients-with-nsclc-after-pemetrexed-or-pembrolizumab-maintenance-100388022","NCT04332367","Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance","Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And\u002FOr Pembrolizumab","Inclusion Criteria:\n\n* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older\n* Prior exposure to 4-6 cycles of Pem\u002FCarbo\u002FPembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.\n* PS 0-1\n\nExclusion Criteria:\n\n* Presence of a driver mutation that is susceptible to targeted therapy\n* Other active invasive malignancy requiring ongoing therapy\n* Grade 2 or higher sensory neuropathy\n* Evidence of untreated brain metastases\n* History of bleeding diatheses or recent, antecedent hemoptysis (\\> 1\u002F2 teaspoon in prior 2 months)",{"count":520,"type":20},59,[224],"The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.",[524],"Non-small Cell Lung Cancer","2026-06-08",{"date":457,"type":31},{"date":528,"type":31},"2020-08-01",{"date":530,"type":20},"2026-09-30",{"name":37,"class":38},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":147,"minAge":17,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":39},"100509651","phase-2-18ffes-petct-in-uterine-cancer-100509651","NCT05916196","[18F]FES PET\u002F.CT in Uterine Cancer","[18F]FLUOROESTRADIOL (FES) PET\u002FCT IMAGING OF THE ESTROGEN RECEPTOR IN PATIENTS WITH METASTATIC OR RECURRENT UTERINE CANCER","Inclusion Criteria\n\n1. Participants will be ≥ 18 years of age\n2. Recurrent or metastatic or intact non-operated uterine cancer not treated with surgery that is biopsy-proven or demonstrated on other standard of care imaging (e.g. CT, FDG PET\u002FCT, MRI, bone scan, x-ray, ultrasound)\n3. At least one lesion outside the liver detected by standard of care imaging (e.g.CT, FDG PET\u002FCT, MRI, bone scan, x-ray, ultrasound)\n4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n5. Subjects that are currently on or have recently discontinued tamoxifen or fulvestrant would require an 8-week or 28-week, respectively, washout period prior to FES PET\u002FCT scan.\n\nExclusion Criteria\n\n1. Females who report they are pregnant at screening will not be eligible for this study. A urine pregnancy test will be performed in women of child-bearing potential prior to FES injection.\n2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n3. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study",{"count":49,"type":20},[224],"Women with known or suspected recurrent or metastatic uterine cancer may be eligible for this study. Patients may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania.\n\n\\[18F\\]fluoroestradiol (FES) PET\u002FCT imaging will be used to evaluate estrogen receptor (ER) activity in areas of disease known by standard of care imaging (e.g. CT, MRI, Bone Scan, FDG PET\u002FCT, ultrasound) or clinical exam. For patients starting a new line of therapy, imaging will occur prior to starting new therapy. For patients who completed an initial scan and are starting new therapy, some patients may also undergo a second FES PET\u002FCT scan at the time of suspected progression of disease to compare for changes in FES uptake measures (prior to initiation of next line therapy). The selection of therapy will be made by a treating physician and will not be affected by participation in this imaging study. Results of the FES PET\u002FCT scan may be shared with the treating physician or subject by request but will not be used to make clinical decisions about treatment.",[503],[544],"estrogen receptor PET imaging","2026-06-04",{"date":547,"type":31},"2026-06-05",{"date":549,"type":31},"2024-04-05",{"date":551,"type":20},"2028-08-01",{"name":37,"class":38},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":21,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":571,"leadSponsor":573,"locationsCount":39},"100597524","phase-2-neoadjuvant-intra-tumoral-rp2-and-flot-in-gastroesophageal-adenocarcinoma-100597524","NCT07059611","Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma","Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site.\n* Patients must have normal organ and bone marrow function, as defined below, less than or equal to 14 days prior to the initiation of study therapy:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n  * Platelets ≥100,000\u002Fmicroliter\n  * Total bilirubin ≤ the institutional upper limit of normal (ULN).\n  * AST and ALT ≤ 2.5 times the institutional ULN\n  * Serum creatinine ≤ 1.5 times the institutional ULN\n  * Hemoglobin ≥ 9 g\u002FdL\n\nExclusion Criteria\n\n* Has received prior chemotherapy, radiation therapy, or immunotherapy (anti-programmed cell death protein-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) for the current malignancy.\n* Per the investigator, has contraindications to receiving chemotherapy with FLOT.\n* Per the sub-investigator (gastroenterologist) responsible for intra-tumoral injections or the investigator, patient has contraindications to repeated upper endoscopy for intra-tumoral injections. These could include medical conditions that would, per the judgment of the sub-investigator or investigator, inappropriately increase the risk of upper endoscopy.\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on warfarin with a target international normalized ratio (INR) ≥ 2.5 that cannot be temporarily reversed to INR ≤ 1.7.\n* Active significant herpetic infections or prior complications of Herpes simplex virus-1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of study treatment.\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: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available COVID-19 vaccines do not contain live virus and are allowed.\n* Has a condition requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10mg\u002Fday of prednisone equivalents are permitted.\n* Prior organ transplantation including allogeneic stem-cell transplantation.\n* Has a previous or concurrent malignancy. Exceptions include:\n\n  * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\n  * Prior malignancy has been completely excised or removed and patient has been continuously disease free for \\> 5-years\n* Has a positive test result for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection with hepatitis B or hepatitis C. Testing will be performed as part of screening on the study.\n\n  * Patients with a known history of hepatitis B or hepatitis C that have been effectively treated (with negative HBsAg and HCV RNA) will be eligible for enrollment on this criterion.\n* Has a known history of human immunodeficiency virus (HIV) with detectable viral load. HIV testing will not be performed as part of screening for the study.\n\n  * Patients with known HIV infection with an undetectable viral load and who are on a stable highly active antiviral regimen per the investigator's assessment will eligible to enroll.\n* Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.",{"count":561,"type":20},34,[224],"The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.",[565,566,567],"Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","2026-06-03",{"date":547,"type":31},{"date":391,"type":20},{"date":572,"type":20},"2029-11-01",{"name":37,"class":38},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":21,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":595},"100388530","phase-2-captemy90-for-grade-23-net-liver-metastases-100388530","NCT04339036","CapTemY90 for Grade 2\u002F3 NET Liver Metastases","UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2\u002F3 Neuroendocrine Tumors","CapTemY90","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)\n* Patients with at least one measurable liver metastases, with size \\> 1cm (RECIST criteria)\n* Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver\n* Liver tumor burden does not exceed 50% of the liver volume\n* Patent main portal vein\n* At least 4 weeks since last administration of last chemotherapy and \u002For radiotherapy\n* Age \\>18 years.\n* Life expectancy of greater than 6 months.\n* ECOG performance status 0-2.\n* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg\u002Fdl, ALT, AST ≤5 times ULN, albumin ≥2.5g\u002Fdl.\n* Patients must have adequate organ and marrow function as defined below:\n* platelets \\>100,000\u002FmcL (may be corrected by transfusion)\n* serum creatinine \\\u003C 2.0 mg\u002Fdl\n* INR \\\u003C1.6, (may be corrected by transfusion)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)\n\nExclusion Criteria:\n\n* Contraindications to capecitibine or temozolomide\n* Contraindicated for both contrast-enhanced MRI and CT\n* Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)\n* Contraindication for radioembolization procedures:\n* excessive hepatopulmonary shunt as determined by the investigator\n* inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures\n* Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.\n* Patients may not be receiving any other investigational agents.\n* Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).\n* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and lactating women are ineligible",{"count":430,"type":20},[224],"This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.\n\nA Grade 3 arm was added in 2025.",[586,587],"Neuroendocrine Tumor Grade 2","Neuroendocrine Tumors","2026-06-02",{"date":545,"type":31},{"date":591,"type":31},"2021-10-07",{"date":593,"type":20},"2028-07-01",{"name":37,"class":38},4,""]