[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UNC Lineberger Comprehensive Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,99,0,25,[9,44,76,105,133,163,184,210,236,263,283,307,339,367,390,420,446,470,495,523,550,571,592,622,653],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100320607","phase-1-ulixertinibpalbociclib-in-patients-with-advanced-pancreatic-and-other-solid-tumors-100320607",false,"NCT03454035","Ulixertinib\u002FPalbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent (no upper age limit)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n4. Tumor Eligibility:\n\n   1. Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care\n   2. Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting\n   3. Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:\n\n      * Tumors molecular profiling genetic aberrations: NRASG12\u002FG13\u002FQ61, KRASG12\u002FG13, HRASG12\u002FG13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled.\n      * Documented disease refractory to at least one PD1\u002FPD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.\n      * Subjects with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint inhibitors due to requirement for immunosuppression\n5. Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort\n6. Life expectancy ≥ 12 weeks\n7. Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib\n\n   Hemoglobin (Hgb) ≥ 9 g\u002FdL Absolute Neutrophil Count (ANC) ≥ 1,500 \u002Fmm3 Platelets ≥ 100,000\u002Fmm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN\n9. Adequate cardiac function; left ventricular ejection fraction (LVEF) \\>50% as assessed by ultrasound\u002Fechocardiography (ECHO) and corrected QT interval (QTc)\n10. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n11. Females of childbearing potential and males must be willing to abstain from heterosexual activity\\* or use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. Acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, OR use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.\\] \\*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n12. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.\n13. Willing to provide archival tissue (if available) and consent to mandatory pretreatment and on-treatment biopsy as deemed safe by the treating physician (expansion cohort only) for research purposes only.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)\n2. Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib\n3. A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n4. Major surgery within 28 days prior to day -6 of ulixertinib\n5. Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4 interaction with the study medications.\n6. Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4 interaction with the study medications\n7. Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to day -6 of ulixertinib; see section 10.3 Appendix C)\n8. Unable or unwilling to discontinue use of any drug known to be a sensitive CYP3A4 substrate with a narrow therapeutic index as defined in the protocol.\n9. Central nervous system metastases are allowed only for patients RAS-mutated and NF1-mutant melanoma cohorts (1) no leptomeningeal disease is present, (2) Intracranial disease is controlled by prior therapies, as evidenced by brain imaging 2 weeks post treatment indicating no new intracranial disease, (3) stable or decreasing dose of steroids is provided patient on ≤ 20mg of prednisone or it's equivalent daily.\n10. Any important medical illness or abnormal laboratory finding that would increase the risk of participating in the study (based on the investigator's judgment)\n11. Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n12. Has a known additional malignancy that is active and\u002For progressive requiring treatment; non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix, prior history of prostate cancer provided the patient is not undergoing active systemic treatment other than hormonal therapy and has documented PSA that is undetectable (\\\u003C0.2ng\u002FmL), prostate carcinoma in remission and did not receive systemic treatment, papillary thyroid cancer did not receive adjuvant radioactive iodine, Stage Rai stage 0 Chronic lymphocytic leukemia does not require systemic treatment, lymphoma, hairy-cell leukemia, or myelodysplasia is in complete remission and or other cancer for which the patient has been disease-free for at least two years.\n\n    Has a known additional malignancy that is active and\u002For progressive requiring treatment.\n13. Impaired GI function or GI disease that may significantly impair absorption (e.g., inflammatory bowel disease (IBD), malabsorption syndrome, small bowel resection, uncontrolled vomiting or diarrhea)\n14. Inability to swallow oral medications\n15. Patients with autoimmune diseases that require systemic corticosteroid treatment \\>20 mg methylprednisolone equivalent.","ALL","18 Years","99 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4\u002F6 inhibitor palbociclib.",[28,29,30],"Tumor, Solid","Pancreatic Cancer","Melanoma","RECRUITING","2026-08-18",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":35},"2018-01-30",{"date":39,"type":22},"2028-02-03",{"name":41,"class":42},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100615550","uniting-trusted-community-messengers-to-improve-access-to-cervical-cancer-screening-in-rural-north-carolina-100615550","NCT07294066","Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina","Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina Aim 3","Woman participants\n\nInclusion Criteria:\n\n* Resident of Lenoir County and 12 community.\n* have not received a Pap test within the last 3.5 years, or an HPV test in the last 5.5 years\n* female ≥ 30 to 64 years of age at time of recruitment\n\nExclusion Criteria:\n\n* 65 years of age or older had a hysterectomy,\n* history of cervical cancer,\n* plan to move from Lenoir County during the study period.\n\nCommunity partners participants\n\nInclusion Criteria:\n\n* community health workers\n* clinic staff\n* community-based organization staff.\n\nExclusion Criteria:\n\n• None",true,"FEMALE","30 Years","64 Years",{"count":56,"type":22},112,[58],"NA","The purpose of this study is to test the feasibility and acceptability of a multi-level, community-engaged intervention to increase access to cervical cancer screening using human papillomavirus (HPV) self-collection (HPVSC) outreach among women living in a high-risk rural county and to improve navigation for follow-up screening.\n\nA one-group intervention evaluation design will be used to pilot test feasibility and acceptability and to assess the proportion of women who return HPVSC kits and test HPV-positive. At the community level, local community-based organizations (CBOs) will serve as HPVSC kit distribution sites. At the individual level, trained community health workers will work with CBOs to support women throughout the HPVSC process, including specimen collection, kit return, result notification, and follow-up clinic-based screening for women who test HPV-positive.",[61,62],"Cervix Cancer","Screen HPV-positive",[64,65,66,67],"Screening","rural","outreach","high risk","NOT_YET_RECRUITING","2026-08-17",{"date":32,"type":35},{"date":72,"type":22},"2026-09",{"date":74,"type":22},"2029-03",{"name":41,"class":42},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":52,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100576773","a-novel-approach-utilizing-organ-specific-age-proteomics-100576773","NCT06789653","A Novel Approach Utilizing Organ Specific Age Proteomics","Investigating Cellular Senescence and Organ Aging in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Novel Approach Utilizing Organ Specific Age Proteomics","Inclusion Criteria:\n\n* Age ≥22years and \\\u003C66 years\n* Diagnosed with early-stage breast cancer (The American Joint Committee on Cancer stages I-III).\n* Understand and read English.\n* Receive care at the study site.\n* Able to understand and participate in study procedures for length of study.\n\nExclusion Criteria:\n\n* Unable to provide consent, unable to communicate verbally.\n* Unable to understand or read English.\n* Enrolled in hospice care.","22 Years","66 Years",{"count":86,"type":22},80,"OBSERVATIONAL","This study compares changes in P16INK4A expression and plasma proteomic signatures of specific organ age pre- and post-chemotherapy in women treated with adjuvant chemotherapy for early-stage breast cancer. It aims to determine if biological and accelerated immune aging, assessed using T cells from peripheral blood, represents aging in different organs.\n\nPatients receiving chemotherapy, especially adjuvant regimens that include anthracyclines and taxanes, often experience late development of cardiac toxicity, functional loss, and cognitive decline. Comparing baseline characteristics with organ aging before therapy might identify patients at the highest risk for chemotherapy complications. For example, this is clinically significant for patients whose therapy includes taxanes or other drugs known to cause peripheral neuropathy. Identifying aging in the neurological or vascular systems before treatment might lead to changes in regimens.\n\nDetermining accelerated aging in specific organs allows for investigating interventions to mitigate organ damage. For instance, identifying patients at the highest risk of cardiac aging after treatment could lead to testing the effects of exercise, senolytics, and other strategies to reduce the risk of long-term heart disease.",[90],"Breast Cancer",[92,93,94,95,96,97,98],"proteomic","plasma proteomic","P16INK4A","chemotherapy","T cells","aging","morbidity",{"date":32,"type":35},{"date":101,"type":35},"2024-10-10",{"date":103,"type":22},"2027-11-01",{"name":41,"class":42},{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":113,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":132,"locationsCount":43},"100570080","virtual-testis-cancer-lay-support-and-survivorship-aim-2-100570080","NCT06702592","Virtual Testis Cancer Lay Support and Survivorship Aim 2","Virtual Testicular Cancer Lay Support and Survivorship (VITALSS Study) Aim 2","VITALSS","Inclusion Criteria:\n\n* Men within 5 years of their initial diagnosis of germ cell testicular cancer.\n* The subject is willing and able to comply with study procedures based on the judgment of the investigator.\n* Adults aged 18-95 years old.\n* Electronic informed consent was obtained to participate in the study.\n\nExclusion Criteria:\n\n* Woman gender\n* Non-English speaking\n* Unwilling or unable to complete informed consent.\n* On active treatment for another cancer.\n* Actively receiving chemotherapy, radiation, or surgery for testicular cancer.","MALE","95 Years",{"count":116,"type":22},360,[58],"This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer. Participants in North Carolina will be randomized into two groups: one with access to a virtual support platform and the other with access to patient educational materials only. After six months, the emotional well-being, self-efficacy, financial toxicity, and quality of life of both groups will be compared at 3 months and 6 months after baseline assessments.",[120,121],"Testicular Cancer","Testis Cancer",[123,124,125,126,127],"virtual support","emotional well-being","self-efficacy","financial toxicity","quality of life",{"date":32,"type":35},{"date":72,"type":22},{"date":131,"type":22},"2028-06",{"name":41,"class":42},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":43},"100538863","discovery-evaluating-a-decision-support-tool-for-adults-seen-in-hematologyoncology-clinics-100538863","NCT06296368","DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology\u002FOncology Clinics","DISCOVERY","Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n1. Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.\n2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n3. Age ≥ 60 years at the time of consent.\n4. New patient to either the hematologic malignancies clinic or the bone marrow transplant\u002Fcellular therapy clinic.\n\nExclusion Criteria\n\nAll subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:\n\n1\\. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention.","60 Years",{"count":142,"type":22},500,[58],"The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.",[146,147,148,149,150],"Hematologic Malignancies","Lymphoma","Multiple Myeloma","Leukemia","Blood Cancers",[152,153,154],"decision support tool","pragmatic study","best-worst scaling","2026-08-12",{"date":157,"type":35},"2026-08-14",{"date":159,"type":35},"2024-06-21",{"date":161,"type":22},"2028-09-01",{"name":41,"class":42},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":43},"100368181","mri-biomarkers-for-radiation-induced-neurocognitive-decline-following-srs-of-newly-diagnosed-brain-mets-100368181","NCT04073966","MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets","Magnetic Resonance Imaging Biomarkers for Radiation-Induced Neurocognitive Decline Following Stereotactic Radiosurgery of Newly Diagnosed Brain Metastases: An Observational Pilot Study","Inclusion Criteria:\n\n* Histologic diagnosis of cancer\n* Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.\n* Patients are permitted to have undergone craniotomy and resection of metastasis\u002Fmetastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.\n* Anticipated life expectancy at least 1 year\n* Age ≥ 18 years\n* Ability to read and comprehend written English and follow instructions in English\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Previous radiation to the brain or head\n* Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years\n* Previous severe head or brain injury\n* History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia\n* Prisoners",{"count":171,"type":22},20,"Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.",[174,175,176,177],"Brain Metastases","Neurocognitive Deficit","White Matter Alterations","Radiation Exposure",{"date":157,"type":35},{"date":180,"type":35},"2019-12-04",{"date":182,"type":22},"2029-05-31",{"name":41,"class":42},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":51,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100651968","evaluating-narrative-vaping-prevention-video-ads-for-adolescents-and-young-adults-100651968","NCT07767929","Evaluating Narrative Vaping Prevention Video Ads for Adolescents and Young Adults","Inclusion Criteria:\n\n* Age 13-20 years old.\n* Current vaper or at risk of vaping. Participants will be considered as a current vaper if they report using e-cigarettes in the past 30 days. Participants will be considered as \"at-risk of vaping\" if they answer anything other than \"definitely not' to 3 screening items assessing their susceptibility to vaping (e.g., \"If one of your best friends were to offer you a vape, would you use it?\" Response options: definitely not, probably not, probably yes, definitely yes).\n* Live in the United States\n\nExclusion Criteria:\n\n* Younger than 13 years or older than 21 years.","13 Years","20 Years",{"count":193,"type":22},1910,[58],"The purpose of this study is to evaluate the persuasive effectiveness of narrative advertisements: with acted-out plots (where characters enact a vaping-related experience) versus narrative advertisements without acted-out plots and control. Using a 3-arm between-subjects randomized design, approximately 1,910 adolescents and young adults (aged 13-20) in the U.S. who vape or are susceptible to vaping will be recruited online. Participants will be randomly assigned to view video ads from one of three conditions (narrative with acted-out plots, narrative without acted-out plots, or control videos) and complete a post-exposure survey evaluating message engagement, emotional response, perceived effectiveness, and psychological reactance.",[197],"Vaping",[199,200,201],"Vaping prevention","Health communication","Tobacco Use","2026-08-11",{"date":69,"type":35},{"date":205,"type":22},"2026-08",{"date":207,"type":22},"2028-08",{"name":41,"class":42},2,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100597681","expanding-the-support-of-family-caregivers-of-diverse-patients-with-cancer-and-diabetes-100597681","NCT07061652","Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes","enCompass","Inclusion Criteria:\n\nInclusion Criteria for Caregivers\n\n* English-speaking.\n* Ability to provide written or verbal informed consent to participate in the study;\n* Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;\n* Be at least 18 years of age at the time of consent; and\n* Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.\n\nInclusion Criteria for patients\n\n* English-speaking\n* Ability to provide informed consent.\n* Be at least 18 years of age at the time of consent; and\n* Their identified caregiver is enrolled in the study\n* Diagnoses: (must have cancer and diabetes)\n* Have a cancer diagnosis for which they are being actively treated at one of the study sites\n* Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy\n* Receiving active cancer treatment s, not including hormonal therapy\n* Concurrent history of diabetes with need for ongoing management\n\nExclusion Criteria:\n\nExclusion Criteria for Caregivers\n\n* Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;\n* Existence of another co-morbid disease other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;\n* Participation in the intervention development phase of this intervention\n\nExclusion Criteria for patients\n\n* Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;\n* Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;\n* Their caregiver does not enroll in the study or withdraws consent",{"count":218,"type":22},162,[58],"This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.\n\nCaregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers.\n\nCaregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs.\n\nPreliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.",[222,223],"Cancer","Diabetes",[225,226],"support application","caregivers","2026-08-06",{"date":229,"type":35},"2026-08-10",{"date":231,"type":35},"2025-07-03",{"date":233,"type":22},"2027-05-01",{"name":41,"class":42},3,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":247,"conditions":248,"keywords":253,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":262,"locationsCount":43},"100650067","phase-2-neoadjuvant-spare-adjuvant-nasa-in-stage-iiib-iv-m1a-melanoma-100650067","NCT07740941","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma","Inclusion Criteria:\n\n* Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of 0-2.\n* Histological confirmation of cutaneous melanoma or melanoma of unknown primary.\n* AJCC stage IIIB\u002FIVa resectable disease that is measurable by iRECIST criteria.\n* Adequate hematologic, renal, hepatic, and heart function\n\nExclusion Criteria:\n\n* Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).\n* Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he\u002Fshe were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.",{"count":244,"type":22},55,[246],"PHASE2","This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.",[249,250,251,252],"Melanoma (Skin Cancer)","Melanoma Stage Stage IIIB","Melanoma Stage M1","Melanoma Stage IV",[254,255,256],"Programmed cell death Protein 1 inhibitor","pembrolizume","ipilimumab","2026-08-03",{"date":259,"type":35},"2026-08-05",{"date":259,"type":22},{"date":74,"type":22},{"name":41,"class":42},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":43},"100633431","phase-2-study-on-treatment-outcome-patterns-for-patients-with-cll-after-discontinuation-of-btk-inhibitors-100633431","NCT07526597","Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors","STOP-CLL-DCT","Inclusion Criteria:\n\nIn order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group Performance Status of 0-3 or Karnofsky Performance Status of ≥40\n* Confirmed of a diagnosis of CLL (Chronic Lymphocytic Leukemia) or SLL (Small Lymphocytic Lymphoma) according to International Workshop on Chronic Lymphocytic Leukemia 2018 Guidelines at any point prior to study enrollment.\n* At the time of enrollment, patients must be receiving treatment with a covalent Bruton tyrosine kinase inhibitor in the first or second line setting and have been receiving this treatment for at a minimum 2 years. Patients may have previously received anti-CD20 monoclonal antibodies (such as rituximab or obinutuzumab) in combination with the cBTKi.\n\nExclusion Criteria:\n\n* Patients must not have evidence of progressive CLL as defined by IWCLL 2018 criteria.\n* Participants with history of malignancy other than CLL\u002FSLL are allowed",{"count":21,"type":22},[246],"This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at least two years. The primary objective is to determine how long patients remain free from disease progression or death after discontinuing treatment, measured as event free survival.\n\nThe study also evaluates whether stopping BTKi therapy leads to improvements in quality of life and reductions in treatment related side effects. Researchers will follow patients over time to assess if the cancer returns, whether resistance to therapy develops, and how patients feel during the treatment free period.\n\nIn addition, the trial will investigate how discontinuing BTKi therapy affects immune function, including whether immune recovery occurs and infection risk decreases.\n\nPreliminary data indicate that patients may experience a treatment free interval exceeding two years after stopping therapy, with associated improvements in quality of life. By prospectively evaluating a time limited treatment strategy, this trial aims to determine whether durable disease control can be maintained off therapy while also assessing the resolution of BTKi related adverse events and changes in patient reported outcomes.\n\nOverall, the study seeks to determine whether patients can safely discontinue BTKi therapy and potentially restart treatment later if needed, thereby maintaining disease control while reducing the burden of continuous therapy.",[274,275],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[277],"Bruton's tyrosine kinase inhibitors (BTKi)",{"date":259,"type":35},{"date":72,"type":22},{"date":281,"type":22},"2032-06",{"name":41,"class":42},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":43},"100523072","phase-1-atlcarcd30ccr4-for-cd30-hl-atlcarcd30ccr4-cells-100523072","NCT06090864","ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells","The Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) and CCR4 for Relapsed\u002FRefractory CD30+ Hodgkin s Lymphoma","During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.\n\nInclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.\n\nExclusion Criteria:\n\n1. Subjects had major surgery within 28 days.\n2. Subject received investigational agents or tumor vaccines within 3 weeks.\n3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.",{"count":291,"type":22},31,[25,246],"Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity.\n\nThe majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib\u002FII study was conducted based on these observations.\n\nThe purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further.\n\nThis is a single-center, open-label phase Ib\u002FII trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.\n\nSubjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.",[295,296,297],"Hodgkin Lymphoma","Relapse","Refractory",[299,300],"cellular therapy","CD30+",{"date":227,"type":35},{"date":303,"type":35},"2024-04-25",{"date":305,"type":22},"2033-07-01",{"name":41,"class":42},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":51,"sex":17,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":324,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":43},"100643735","strength-training-exercise-in-pediatric-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-step-all-100643735","NCT07634653","Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)","STEP-ALL","Inclusion Criteria for children:\n\nAll subjects must meet the following criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental\u002Flegal guardian consent.\n* Age \\>= 6 and \\\u003C =21 years at the time of diagnosis.\n* Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma\n\nExclusion Criteria for children:\n\n* Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.\n* Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.\n\nOptional caregiver participation:\n\nInclusion Criteria :All caregivers must meet the following criteria\n\n* Written informed consent to participate in the caregiver interviews.\n* The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \\\u003C18 years","6 Years",{"count":316,"type":22},40,[58],"Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.\n\nTreatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.\n\nEffective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.\n\nThis study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.",[149,320,321,322,323],"Acute Leukemia","Acute Lymphoid Leukemia","Lymphoblastic Lymphoma","Acute Lymphoblastic Leukemia",[325,326,327,328,329,330,331],"children","pediatric","weight gain","body mass index (BMI)","physical activity","Exercise","hybrid exercise program","2026-07-31",{"date":257,"type":35},{"date":335,"type":35},"2026-05-01",{"date":337,"type":22},"2028-06-01",{"name":41,"class":42},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":349,"briefSummary":350,"conditions":351,"keywords":356,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":366},"100619124","phase-2-evolutionary-clinical-trial-for-novel-biomarker-driven-therapies-100619124","NCT07340541","Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies","TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)","EVOLVE-BDT","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years of age at the time of consent\n* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).\n* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol\n\nExclusion Criteria:\n\n* Inaccessible metastatic lesion to research biopsy\n* Subject has already initiated 2nd line therapy\n* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation",{"count":348,"type":22},700,[246],"This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive\u002Fhormone receptor-negative (ER+\u002FHR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.",[90,352,353,354,355],"Metastatic Breast Cancer","Triple Negative Breast Cancer","Estrogen-receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[357,358],"biomarker directed therapies","biomarker stratified trial","2026-07-30",{"date":332,"type":35},{"date":362,"type":35},"2026-02-16",{"date":364,"type":22},"2031-06-02",{"name":41,"class":42},4,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":43},"100542761","phase-1-study-of-autologous-car-t-cells-targeting-b7-h3-in-tnbc-ic9-carb7-h3-t-cells-100542761","NCT06347068","Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells","Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:\n\n1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60% (see APPENDIX VI- Karnofsky Scale))\n4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)\n\n   1. ER- and PR-negative: defined as \\\u003C 1% staining by immunohistochemistry (IHC)\n   2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \\\u003C 2.0\n\nExclusion Criteria:\n\n1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.\n2. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1",{"count":375,"type":22},42,[25],"This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed\u002Frefractory triple-negative breast cancer (TNBC).",[90,296,379,353],"Resistant Cancer",[299,381],"biologic therapy","2026-07-27",{"date":384,"type":35},"2026-07-28",{"date":386,"type":35},"2024-06-27",{"date":388,"type":22},"2030-05",{"name":41,"class":42},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":410,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":43},"100639751","phase-2-effects-of-infusion-timing-on-treatment-response-in-solid-tumors-100639751","NCT07630168","Effects of Infusion Timing on Treatment Response in Solid Tumors","Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors","TIMED","Inclusion Criteria:\n\nCohort 1A and 1B:\n\n* Participants with metastatic non-small cell lung cancer (NSCLC).\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nCohort 2A and 2B:\n\n* Participants with resectable head and neck squamous cell carcinoma (HNSCC)\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement\n* of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nExclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)\n\n* Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.\n* Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.",{"count":399,"type":22},238,[246],"This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.",[403,404,405,406,407,408,409],"Lung Cancer","Non-small Cell Lung Cancer","Metastatic Lung Cancer","Head and Neck Cancer","Metastatic Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Resectable Head and Neck Squamous-cell Carcinoma",[411,412],"programmed cell death protein 1","programmed death-ligand 1","2026-07-24",{"date":382,"type":35},{"date":416,"type":22},"2026-08-01",{"date":418,"type":22},"2033-01-01",{"name":41,"class":42},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":435,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":43},"100639526","pilot-study-of-communication-for-dual-users-of-cigarettes-and-e-cigarettes-100639526","NCT07599462","Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes","Designing and Evaluating Communication for Dual Users of E-cigarettes and Combustible Cigarettes","Inclusion Criteria:\n\n* use cigarettes every day or some days\n* use e-cigarettes every day or some days\n* age 18 or older\n* ability to read and answer questions in English\n\nExclusion Criteria:\n\n* under age 18",{"count":428,"type":22},90,[58],"The study is a pilot test of effectiveness of communication campaign ads on interest in quitting combustible cigarettes and e-cigarettes. Over the course of 5 weeks, participants are sent ads that are designed to encourage quitting and then answer surveys.",[432,433,434],"Tobacco Products","Cigarettes","Electronic Cigarettes",[436,437,438],"dual use","tobacco cesation","communication campaign","2026-07-21",{"date":441,"type":35},"2026-07-23",{"date":443,"type":35},"2026-04-24",{"date":72,"type":22},{"name":41,"class":42},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":458,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":43},"100521705","grid-therapy-for-extremity-soft-tissue-sarcoma-100521705","NCT06073067","GRID Therapy for Extremity Soft Tissue Sarcoma","Safety, Efficacy, and Mechanism of Pre-operative Spatially Fractionated GRID Radiation Therapy in Patients With Extremity Soft Tissue Sarcoma: A Pilot Study","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n1. Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n2. Age ≥ 18 years at the time of consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2 (Karnofsky Performance Status equivalent of 50 - 100).\n4. Histological or cytological evidence\u002Fconfirmation of extremity soft tissue sarcoma as determined by core-needle biopsy or excision biopsy. If the diagnostic tissue is not available or sufficient to perform correlative studies, must be willing to provide the mandatory pre-treatment core-needle biopsy. In some cases of extremity STS, subjects undergo an attempted surgical resection for a presumed benign condition and the specimen reveals malignancy. Such subjects are allowed so long as a complete, oncologic, resection was not performed\u002Fattempted and there is ≥ 5 cm of the remaining primary tumor.\n\nExclusion Criteria:\n\nSubjects meeting any of the exclusion criteria listed below at baseline will be excluded from the study.\n\n1. Subjects who have received prior radiotherapy to the tumor site.\n2. Subjects who have undergone complete tumor resection of the primary tumor or who have developed tumor recurrence after resection.\n3. History of serious or non-healing wound, ulcer, or bone fracture in the treatment limb within the last 5 years.\n4. History of clinically significant lymphedema in the treated limb.\n5. History of lupus, scleroderma, Sjogren's syndrome, Ehlers-Danlos syndrome (any type), or other collagen vascular disease that may pose a relative contraindication, due to increased risk of skin or soft tissue toxicity, with radiation.",{"count":171,"type":22},[58],"Patients with extremity soft tissue sarcoma (STS) are at high risk of recurrence. Pre-operative radiotherapy is used to increase the safe removal of tumors and improve local control in these patients. Increasing the preoperative radiotherapy dose with standard techniques might lead to normal tissue toxicity and postoperative wound complications.\n\nGRID radiation therapy is a technique that may increases radiation dose with minimal added toxicity. It is hypothesized that GRID radiation dose will improve tumor response without increasing post-operative wound complications. While GRID has been used in many patients, there have been few formal studies to evaluate the safety and efficacy of the technique. In this study, a single priming dose of GRID will be administered to subjects with high-risk extremity soft tissue sarcoma prior to standard radiotherapy and tumor resection to determine the safety and clinical efficacy of the GRID dose. This single-arm pilot study will assess the safety of spatially fractionated grid radiation therapy (GRID) on 20 subjects with resectable extremity soft tissue sarcoma, followed by standard-of-care conventional radiotherapy (XRT) and tumor resection.",[457],"Sarcoma",[459,460,461,462,463],"extremity","radiation","GRID","surgery","preoperative",{"date":441,"type":35},{"date":466,"type":35},"2023-11-09",{"date":468,"type":22},"2027-11-10",{"name":41,"class":42},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":43},"100521878","improving-thoracic-surgical-care-using-electronic-patient-reported-outcomes-epros-100521878","NCT06075316","Improving Thoracic Surgical Care Using Electronic Patient-Reported Outcomes (ePROS)","Inclusion Criteria:\n\nPatients participating in ePRO monitoring must meet the following inclusion criteria to participate in this study:\n\n1. 18 years or older\n2. English or Spanish speaking\n3. Able to complete a web-based, telephonic (IVR), or CRA (or other IRB-approved research team member)-administrated symptom survey\n4. Planned to undergo major thoracic surgery (involving chest wall incisions and overnight admission)\n5. Discharged from the thoracic surgery service\n6. Discharged to home\n\nExclusion Criteria:\n\nAll patients meeting any of the following exclusion criteria at enrollment will be excluded from study participation:\n\n1. Not completing planned surgery within 3 months of obtaining informed consent\n2. Inability to understand English or Spanish\n3. Having undergone only minor thoracic surgery (e.g. bronchoscopy, cervical mediastinoscopy)\n4. Dementia, altered mental status, or any psychiatric condition determined by the thoracic surgery provider team that would prohibit the understanding or rendering of informed consent.\n5. Current incarceration\n6. Pregnancy",{"count":477,"type":22},200,[58],"This is a single-site, non-randomized study on the outcomes of remote real-time \"ePRO monitoring\" in thoracic surgery patients. ePRO monitoring is a health information technology intervention comprised of delivering longitudinal electronic patient-reported outcome (ePRO) surveys (e.g., on symptoms, and physical functioning) coupled with automated provider alerts for concerning survey responses.",[481],"Thoracic",[483,484,485,486],"Electronic Patient-Reported Outcome","Patient-Reported Outcome","thoracic surgery","complications","2026-07-14",{"date":489,"type":35},"2026-07-16",{"date":491,"type":35},"2023-11-14",{"date":493,"type":22},"2026-12-31",{"name":41,"class":42},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":510,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":522,"locationsCount":43},"100584961","progress-precision-oncology-using-genomic-reflexive-evaluations-for-study-selection-and-survival-100584961","NCT06896162","PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival","PROGRESS","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0-2.\n* Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer\n* The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting\n* A genomic tumor test has not been ordered or has been ordered but not resulted.\n\nExclusion Criteria:\n\n• Subjects with an active concurrent malignancy.",{"count":142,"type":22},[58],"This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for patients with stage IV solid tumor malignancies (breast, lung, colorectal, and bladder cancers).\n\nThe purpose of this study is to investigate whether intervention from a centralized precision oncology navigator and expert review of NGS results by the precision oncology pharmacist will increase ordering of Level 1\u002F2 genome informed therapy (GIT) compared to an estimated historical rate of 15%. Secondary endpoints will assess the impact of a centralized precision oncology navigator and expert review of NGS results on enrollment in biomarker-directed clinical trials and overall survival at 2 years after return of NGS results. The study will take approximately 12 months for enrolment and 2 years of follow-up after the date of NGS results.",[506,507,90,508,403,509],"Solid Tumor Malignancies","Metastatic Cancer","Colorectal Cancer","Bladder Cancer",[511,512,513,514,515,516],"next-generation sequencing (NGS)","expert review of NGS","precision oncology","precision oncology navigator","genome informed therapy (GIT)","biomarker-directed clinical trials","2026-07-10",{"date":487,"type":35},{"date":520,"type":35},"2025-06-27",{"date":131,"type":22},{"name":41,"class":42},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":530,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":23,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":43},"100592135","implementation-of-an-oral-chemotherapy-adherence-intervention-100592135","NCT06989489","Implementation of an Oral Chemotherapy Adherence Intervention","Design and Implementation of a Social Cognitive Theory-based Medication Adherence Intervention","Inclusion Criteria:\n\n* Adult (age ≥21 years-old) patients\n* Diagnosed with a solid or hematologic malignancy\n* Monotherapy on oral anticancer agent on treatment for at least 6 months\n\nExclusion criteria:\n\n* Patients on time-limited or intermittent therapy (non-continuous)\n* Patients on comfort (end-of-life) care\n* Patients enrolled on hospice","21 Years",{"count":532,"type":22},160,[58],"The goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). The study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months.\n\nThis study will have two groups of participants, a pre- and post-implementation group. In the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. Similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. These patients will be administered the same survey. The results from both groups will be analyzed to see how effective the medication adherence program is.",[536,537],"Solid Tumor","Hematologic Malignancy",[539,540,541],"oral anticancer agent","oral chemotherapy","adherence","2026-07-06",{"date":544,"type":35},"2026-07-08",{"date":546,"type":35},"2025-05-28",{"date":548,"type":22},"2028-08-30",{"name":41,"class":42},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":564,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":43},"100523465","phase-1-autologous-car-t-cells-targeting-cspg4-in-relapsedrefractory-hnscc-100523465","NCT06096038","Autologous CAR-T Cells Targeting CSPG4 in Relapsed\u002FRefractory HNSCC","Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent\u002Fmetastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.",{"count":558,"type":22},33,[25],"The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.",[406,296,562,563],"Recurrent","Refractory Cancer",[299],{"date":544,"type":35},{"date":567,"type":35},"2024-04-05",{"date":569,"type":22},"2028-08-01",{"name":41,"class":42},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":43},"100511301","incorporating-biometric-data-for-patients-receiving-concurrent-chemotherapy--rt-100511301","NCT05937659","Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT","Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy","Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nSubjects\n\n1. All genders aged ≥ 18 years of age.\n2. English-speakers\n3. Able to understand and cooperate with study procedures.\n4. Signed and dated informed consent.\n5. Subjects being seen at Novant-New Hanover Regional Medical Center for diagnosis and management of cancer.\n6. Subjects prescribed to receive concurrent radiation therapy and systemic therapy either definitively or postoperatively.\n7. Signed and dated HIPAA authorization for the release of personal health information.\n\nProviders\n\n1. All genders aged ≥ 18 years of age.\n2. English speakers.\n3. Able to understand and cooperate with study procedures.\n4. Signed and dated informed consent.\n\nExclusion Criteria Both Subjects and care providers\n\n1\\. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent",{"count":171,"type":22},"This study will assess the feasibility of incorporating biometric data via wearable health technology (WHT) into the radiation oncology (RO) clinic workflow for patients receiving concurrent radiation therapy and systemic therapy (CRT) for cancer. The investigators hypothesize that a practical workflow could be created within a busy community RO practice that will allow providers and patients to readily appreciate physiologic declines during concurrent CRT.\n\nSubjects will be asked to wear a device as part of this study that will collect their biometric data (heart rate, number of steps taken per day, etc) called a WHT device throughout their treatment and for 4 weeks afterward. Subjects will be asked to upload the data from their devices onto the computers in the clinic for the assessment.",[222],[582,95,583,584],"radiation therapy","biometric data","wearable health technology",{"date":586,"type":35},"2026-07-07",{"date":588,"type":22},"2026-09-15",{"date":590,"type":22},"2027-10-30",{"name":41,"class":42},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":607,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":43},"100643366","phase-2-olomorasib--pembrolizumab-kras-g12c-mutant-pd-l1-tps-1-49-locally-advanced-or-metastatic-nsclc-100643366","NCT07639242","Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC","Olomorasib Plus Pembrolizumab as First-Line Treatment for KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up until the point at which the subject receives treatment for the subject to be considered eligible for treatment.\n\nInclusion Criteria:\n\nIn order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.\n\nWritten informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group performance status (ECOG) of 0-2\n* Subjects must have previously untreated, Stage IIIB-IIIC or Stage IV Non-Small Cell Lung Cancer (NSCLC) not amenable to curative intent treatment.\n* Measurable disease according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1 within 28 days prior to treatment\n* Known KRAS G12C mutation identified on tumor tissue or circulating tumor DNA (ctDNA) as determined by molecular testing performed in a CLIA, CAP or other similarly certified laboratory per local guidelines.\n* Subjects must have a known PD-L1 tumor proportion score (TPS) of 1-49% as determined by an IHC assay in a CLIA, CAP, or other similarly certified laboratory as per local guidelines\n\nExclusion Criteria:\n\n• Subject has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest and uncontrolled disease-related pericardial effusion or pleural effusion.",{"count":600,"type":22},60,[246],"This clinical trial evaluates the combination of olomorasib and pembrolizumab as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a Kirsten Rat Sarcoma Virus (KRAS) G12C mutation and a programmed death-ligand (PD-L1) score between 1% and 49%. The main goal of the study is to determine how long patients live without their cancer worsening after starting treatment, also known as progression-free survival (PFS). Additional goals include evaluating how many patients experience tumor shrinkage or disappearance, how long responses to treatment last, overall survival, and the safety and side effects of the treatment combination. Furthermore, how well the treatment works in patients whose cancer has spread to the brain, outcomes in patients with a lower Eastern Cooperative Oncology Group performance status (ECOG), and whether certain tumor or blood-based biomarkers are associated with treatment response or side effects, if enough patient data is available for analysis.",[403,604,605,606],"Lung Cancer (NSCLC)","Locally Advanced NSCLC","Metastatic NSCLC - Non-Small Cell Lung Cancer",[608,609,610,611,612,613],"olomorasib","pembrolizumab","KRAS G12C+mutant","Kirsten Rat Sarcoma Virus G12C+ mutant","programmed death-ligand","PD-L1","2026-06-30",{"date":616,"type":35},"2026-07-02",{"date":618,"type":22},"2026-06",{"date":620,"type":22},"2030-06-21",{"name":41,"class":42},{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":639,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":43},"100646875","phase-2-pharmacologic-therapies-to-mitigate-radiation--associated-heart-disease-100646875","NCT07685938","Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA\n* authorization for release of personal health information.\n* Subjects is willing and able to comply with study procedures based on the\n* judgement of the investigator.\n* Consent for serial blood draws and consent for use of biological specimens.\n* Age ≥ 18 years at the time of consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Pre-existing use of a statin or ACE-inhibitor\n* Pre-existing hypotension",{"count":600,"type":22},[246],"Radiation therapy is an essential treatment for tumors in the chest area, including breast, lung, esophageal, mediastinal cancers, and spine metastases. Although technical advances have reduced treatment-related illness and death, radiation exposure to the heart can still cause substantial rates of radiation-induced heart disease (RIHD) among survivors.\n\nFor example, about 21% of non-small cell lung cancer patients receiving a mean heart dose of 20 Gy or higher experience major adverse cardiac events (MACE) within 2 years. In breast cancer patients, the risk of MACE increases by about 7% for each additional Gy of mean heart dose.\n\nThere is currently no established medication strategy to prevent or reduce RIHD.\n\nPreclinical and clinical studies show that statins and angiotensin-converting enzyme (ACE) inhibitors may help reduce radiation-induced heart disease (RIHD). Statins and ACE inhibitors are generally well tolerated, available as generic drugs, and commonly used to help prevent cardiovascular disease. They may protect the heart by reducing damage to blood vessel lining (endothelial damage), microvascular dysfunction, atherosclerosis, reduced blood flow (ischemia), and fibrosis (scarring).\n\nThis study is a prospective, randomized, placebo-controlled phase II hybrid decentralized trial. Patients receiving standard radiation therapy and expected to receive an equivalent dose of at least 25 Gy (EQD2) to at least 10% of the heart will be randomly assigned to receive either:\n\n* placebo, or\n* Atorvastatin 20 mg plus Lisinopril 5 mg daily. The medications will be taken during radiation therapy and continued for 6 months after treatment.\n\nThe study aims to determine whether the intervention can reduce radiation-related decreases in blood flow to the heart, measured using myocardial perfusion imaging, such as positron emission tomography (PET), which is commonly used to evaluate the risk of coronary heart disease.",[632,90,403,633,634,635,636,637,638],"Chest Wall Tumor","Esophageal Cancer","Mediastinal Cancers","Spine Metastases","Spinal Tumor","Thoracic Cancer","Thoracic Neoplasms",[582,98,640,641,642,643,644,645],"mortality","radiation induced heart disease","major adverse cardiac events","placebo-controlled","angiotensin-converting enzyme (ACE) inhibitors","statins","2026-06-29",{"date":542,"type":35},{"date":649,"type":22},"2026-07",{"date":651,"type":22},"2029-02",{"name":41,"class":42},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":660,"briefSummary":661,"conditions":662,"keywords":669,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":677,"locationsCount":43},"100582251","combating-cancer-related-fatigue-a-personalized-supportive-care-program-100582251","NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention",{"count":316,"type":22},[58],"This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[663,147,274,275,664,665,666,667,668],"Indolent Lymphomas","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Waldenstrom Macroglobulinemia","Cutaneous T Cell Lymphoma",[670,671],"exercise","dietary intervention",{"date":673,"type":35},"2026-07-01",{"date":675,"type":35},"2025-06-03",{"date":493,"type":22},{"name":41,"class":42},""]