[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,50,96,173,194,221,245,277,307,338,367,403,430,449,475,501,529,548,588,616,655,684,706,733,765],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100611941","developing-and-testing-the-effectiveness-of-a-skin-cancer-self-detection-educational-program-100611941",false,"NCT07247123","Developing and Testing the Effectiveness of a Skin Cancer Self-Detection Educational Program","Protocol for Developing and Testing the Effectiveness of a Skin Cancer Self-Detection Educational Program: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Individuals aged 16 and above\n* Able to read and converse in English\n* Able to provide informed consent\n* Having the ability to use and interact with a web server or application.\n\nExclusion Criteria:\n\n\\- Individuals who have cognitive impairment or decline to participate. There will be no exclusion criteria based on a previous history of skin cancer.",true,"ALL","16 Years",{"count":21,"type":22},280,"ESTIMATED","INTERVENTIONAL",[25],"NA","Skin cancer is a significant public health concern, even in an Asian society like Singapore where it ranks among the top 10 cancers. This RCT tests the effectiveness of a skin cancer educational intervention to improve skin cancer outcomes among skin-of-color individuals, including the effects of gain versus loss framing.",[28,29,30],"Skin Cancer","Skin Cancer Prevention","Benign Skin Growth",[32,33,34,35,36],"skin cancer","skin cancer education","skin cancer intervention","patient education","digital education","RECRUITING","2026-06-29",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"2026-06-15",{"date":45,"type":22},"2027-12",{"name":47,"class":48},"National University Hospital, Singapore","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":78,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).","18 Years",{"count":60,"type":22},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[64,65,66,67,68,69,70,71,72,73,74,75,76,28,77],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Melanoma (Skin Cancer)",[65,79,80,64,81,82,83,84,85,86],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":38,"type":41},{"date":90,"type":41},"2025-04-14",{"date":92,"type":22},"2038-04",{"name":80,"class":94},"INDUSTRY",8,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":17,"sex":18,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":107,"studyType":61,"phases":4,"briefSummary":108,"conditions":109,"keywords":155,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals","19 Years","110 Years",{"count":106,"type":22},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[110,111,112,113,114,115,116,117,118,119,120,121,122,75,123,124,125,126,67,74,127,128,129,130,131,132,133,134,135,136,137,138,139,140,28,141,142,143,144,145,146,147,148,149,150,72,151,152,153,154],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[110,111,156,157,158,159,160,161,162,163,144,164,153,154],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":38,"type":41},{"date":167,"type":41},"2013-11-01",{"date":169,"type":22},"2099-12",{"name":171,"class":48},"University of Nebraska",42,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":49},"100624160","optical-characterization-and-multi-modality-multi-scale-modeling-of-human-skin-applied-to-cancer-diagnosis-100624160","NCT07406022","Optical Characterization and Multi-modality, Multi-scale Modeling of Human Skin Applied to Cancer Diagnosis.","OpticSkin","Inclusion Criteria:\n\n* patients with skin carcinomas and actinic keratoses\n\nExclusion Criteria:\n\n* minor patient",{"count":181,"type":22},140,"Skin carcinomas are the most commonly diagnosed cancers in fair-skinned populations, for example in France, Western Europe, and North America in particular. The OpticSkin project will build and make available to the general public and the scientific and medical community a histological and optical spectroscopic database of healthy, precancerous, and cancerous human skin in terms of absorption, elastic and inelastic scattering (Raman), steady-state and time-resolved autofluorescence, and polarization. The aim is to identify spectroscopic signatures that will be useful for diagnosis.",[28,184],"Diagnostic","2026-06-23",{"date":187,"type":41},"2026-06-24",{"date":189,"type":41},"2025-12-01",{"date":191,"type":22},"2029-12-31",{"name":193,"class":48},"Centre Hospitalier Régional Metz-Thionville",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100563397","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-scc-for-immunocompromised-patients-100563397","NCT06615635","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous SCC for Immunocompromised Patients","A Pivotal, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of Intratumoral Alpha DaRT224 for the Treatment of Immunocompromised Patients With Cutaneous Squamous Cell Carcinoma","DaRT","Inclusion Criteria:\n\n* 1\\. Patients with cutaneous SCC histologically confirmed 2. Histopathological confirmation within 6 months of enrollment provided no tumor treatment occurred between the biopsy and enrollment 3. Immunocompromised due to any primary or secondary immunodeficiencies Measurable disease according to RECIST v 1.1.\n\n  4\\. Patient able and willing to undergo multiple CT scans 5. Tumor size ≤7 cm, at the longest diameter. 6. Single lesion per subject. 7. Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds. Targets will be deemed technically amenable for complete coverage if there are entry and exit vectors for placement that are not hindered by bone or major vessels or other vital organs (eg. eye) as decided by treating physician and sponsor.\n\n  8\\. Interstitial implant indication validated by multidisciplinary team. 9. ECOG Performance Status ≤2. 10. Life expectancy ≥12 months. 11. Subjects male\u002F female ≥18. 12. Willing and have the ability to provide signed Informed Consent. 13. Patients, male and female, with reproductive potential (including women who are menopausal for less than a year and not surgically sterilized), must practice acceptable effective methods of birth control, such as barrier methods, condom or diaphragm with spermicide or abstinence. Birth control should be continued for 1 year after the DaRT insertion visit.\n\n  14\\. Women with childbearing potential must provide a negative pregnancy test during the screening period and up to V1, prior to the DaRT insertion procedure.\n\n  15\\. Blood tests values:\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST ≤2.5xULN,\n  * SGOT ≤2.5xULN,\n  * SGPT ≤2.5xULN,\n  * Alkaline Phosphatase ≤2.5xULN.\n  * Creatinine Clearance ≥30 ml\u002Fmin.\n  * INR or Prothrombin time ≤1.5xULN.\n\nExclusion Criteria:\n\n* 1\\. Distant or nodal metastatic disease (according to the TNM staging system - N+ or M1 patients are excluded).\n\n  2\\. T4 disease 3. extensive PNI 4. Previously untreated cutaneous SCC 5. Mucosal SCC. 6. Inability to fully cover the entire volume with DaRT seeds 7. Inability to place DaRT seeds into tumor due to inaccessibility by presence of bones or major vessels or vital organs 8. Inability or unwillingness to undergo multiple CT scans 9. Patients receiving any of the following within 4 weeks of enrollment:\n  1. Antineoplastic systemic chemotherapy or biological therapy\n  2. Immunotherapy\n  3. Investigational agents other than the study intervention\n  4. Radiation therapy\n  5. Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial.\n\n     10\\. Longest tumor diameter \\>7 cm. 11. Tumor with keratoacanthoma histology. 12. Known hypersensitivity to any component of treatment. 13. Clinically significant cardiovascular disease e.g., cardiac failure of New York Heart Association class III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, history of myocardial infarction in the last 12 months.\n\n     14\\. Any medical or Psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to tolerate treatment and to adhere to the clinical trial protocol.\n\n     15\\. Serious medical comorbidities that, in the opinion of the investigator, may affect subject compliance and\u002For interpretation of treatment safety or effectiveness.\n\n     16\\. High probability of protocol non-compliance (in opinion of investigator). 17. Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n\n     18\\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n\n     19\\. Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry and for 1 year after the DaRT insertion visit.\n\n     20\\. Breastfeeding or pregnant women 21. Tattoos scars, body jewelry (e.g., nose rings) or other identifying marks which cannot be adequately hidden on digital photos or other identifying marks which cannot be adequately hidden on digital photos",{"count":203,"type":22},28,[25],"This is a multi-center clinical study enrolling up to 28 participants. The primary objectives are to determine the objective response rate (ORR) established by the confirmed best overall response (BOR) following intratumoral administration of DaRT - Diffusing Alpha-Emitters Radiation Therapy. Secondary objectives are to:\n\n1. Determine Progression Free Survival (PFS) up to 12 months after Alpha DaRT sources insertion.\n2. Assess Overall Survival (OS) of patients treated with DaRT up to 12 months.\n3. Assess Local control up to 12 months after DaRT insertion.",[207,208,209,210,28,211],"Squamous Cell Carcinoma","Alpha Radiation","Immunocompromised","Carcinoma, Squamous","Brachytherapy",{"date":213,"type":41},"2026-06-16",{"date":215,"type":41},"2026-01-01",{"date":217,"type":22},"2026-12",{"name":219,"class":94},"Alpha Tau Medical LTD.",11,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100539045","high-intensity-exercise-and-high-fiber-diet-for-immunotherapy-outcomes-in-melanoma-patients-the-duo-trial-100539045","NCT06298734","High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically diagnosed with melanoma.\n* Having been or newly receiving immunotherapy for at least one month.\n* Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Ability to understand and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.\n* Consuming ≥ 30 grams\u002Fday of dietary fiber over the past month.\n* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.\n* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).\n* Patients who are non-English speaking and cannot complete the participant surveys.",{"count":229,"type":22},40,[25],"The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.\n\nThe names of the groups in this research study are:\n\n* High-Intensity Exercise (EX)\n* High-fiber Diet (DT)\n* Combined High-Intensity Exercise and High-Fiber Diet (COMB)\n* Attention Control (AC)",[233,28,234],"Melanoma (Skin)","Advanced Melanoma",[146,28,234],{"date":237,"type":41},"2026-06-17",{"date":239,"type":41},"2024-07-01",{"date":241,"type":22},"2027-03-31",{"name":243,"class":48},"Fred Hutchinson Cancer Center",2,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":49},"100403501","alpha-radiation-emitters-device-dart-for-the-treatment-of-cutaneous-mucosal-or-superficial-soft-tissue-neoplasia-100403501","NCT04534127","Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia","A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia","Inclusion Criteria:\n\n* Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds\n* Brachytherapy indication validated by a multidisciplinary team\n* Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.\n* Measurable disease according to RECIST v1.1.\n* Subjects over 18 years old.\n* Subjects' ECOG Performance Status Scale is \\\u003C 2.\n* Subjects' life expectancy is more than 6 months.\n* Platelet count ≥100,000\u002Fmm3.\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* AST and ALT ≤ 2.5 X ULN\n* International normalized ratio of prothrombin time ≤1.8.\n* Creatinine ≤1.9 mg\u002FdL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Subjects are willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Subject has a tumor of Keratoacanthoma histology.\n* Known hypersensitivity to any of the components of the treatment.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids\n* Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Subjects not willing to sign an informed consent.\n* Women who are pregnant or breastfeeding.",{"count":253,"type":22},56,[25],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia",[28,257,258],"Mucosal Neoplasm of Oral Cavity","Soft Tissue Neoplasm",[207,260,28,261,262,210,263,264,265,266,267,268,269,270,211],"SCC","Skin metastasis","HNSCC","CMN","Basal cell carcinoma","Superficial sarcoma","Kaposi sarcoma","Alpha radiation","Cutaneous lesion","Tongue cancer","Lip cancer",{"date":213,"type":41},{"date":273,"type":41},"2020-12-22",{"date":275,"type":22},"2027-07-01",{"name":219,"class":94},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":244},"100367735","alpha-radiation-emitters-device-dart-for-the-treatment-of-of-malignant-cutaneous-tumors-100367735","NCT04068155","Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors","A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors","Inclusion Criteria:\n\n* Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:\n\n  * SCC\n  * BCC\n  * Lentigo maligna melanoma (Dubreuilh melanoma)\n  * Carcinosarcoma\n* Acceptable tumor locations include the following:\n\n  * Skin (facial, scalp, extremities, torso)\n  * Lips\n  * Eyelids\n* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.\n* Measurable disease according to RECIST v1.1.\n* Subjects over 18 years old.\n* Subjects' ECOG Performance Status Scale is \\\u003C 2.\n* Subjects' life expectancy is more than 6 months.\n* Platelet count ≥100,000\u002Fmm3.\n* International normalized ratio of prothrombin time ≤1.8.\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.\n* Subjects are willing to sign an informed consent form\n\nExclusion Criteria:\n\n* Subject has a tumor with histology of one of the following:\n\n  * Keratoacanthoma\n  * Merkel cell carcinoma\n  * Sarcoma other than carcinosarcoma\n* Metastatic disease (according to the TNM staging system - M1 patients are excluded)\n* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Subjects not willing to sign an informed consent.\n* Women who are pregnant or breastfeeding.",{"count":285,"type":22},80,[25],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors",[28,289,290],"Cutaneous Tumor","Cutaneous Metastasis",[207,292,28,293,294,208,295,211,296,297,298,299,270,300,260],"Basal Cell Carcinoma","Skin Metastasis","Superficial Sarcoma","Cutaneous Lesion","Radiotherapy","Lentigo maligna melanoma","Carcinosarcom","scalp cancer","Eyelid cancer",{"date":213,"type":41},{"date":303,"type":41},"2022-04-01",{"date":305,"type":22},"2028-01",{"name":219,"class":94},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":17,"sex":18,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":244},"100549893","rural-adult-and-youth-sun-protection-study-100549893","NCT06439979","Rural Adult and Youth Sun Protection Study","Rural Adult and Youth Sun Protection Study - Rural Baseball R01","RAYS","Parent inclusion criteria:\n\ni. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)\n\nii. Live and\u002For work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems)\n\nCoach\u002Fleader inclusion criteria:\n\ni. Adults who serve as coaches or leaders of recreational sports (i.e. baseball\u002Fsoftball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older\n\nii. Live and\u002For work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)\n\nParticipant inclusion criteria for minor participants (ages 3 and older) are as follows:\n\ni. Live in rural communities and\u002For participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).\n\nParticipant inclusion criteria for key informant interviews are as follows:\n\ni. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and\u002For adults who currently have minor children 3 years of age or older playing on participating sports teams and\u002For adults who live and\u002For work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)\n\nLocal sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball\u002Fsoftball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older.\n\nExclusion Criteria:\n\n* Adults and children who do not speak or read English will be excluded.\n* For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.","3 Years","7 Years",{"count":318,"type":22},843,[25],"The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia.",[233,28],[323,324,325,326,327,328],"Rural","Melanoma, Skin cancer","Prevention","Underserved communities","Youth","Sports","2026-06-10",{"date":331,"type":41},"2026-06-12",{"date":333,"type":41},"2024-04-08",{"date":335,"type":22},"2030-04",{"name":337,"class":48},"University of Utah",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":348,"conditions":349,"keywords":353,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":244},"100614955","early-phase-1-a-randomized-controlled-trial-of-topical-5-niacinamide-for-skin-cancer-prevention-in-transplant-recipients-100614955","NCT07286318","A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients","Inclusion Criteria:\n\nAge ≥18 History of solid organ transplantation At least 5 AKs in the past year or prior history of skin cancer Participants are willing to continue using SPF30 sunscreen from their own supply\n\nExclusion Criteria:\n\nKnown allergy to niacinamide or sunscreen components Eczema or other skin conditions for which niacinamide is contraindicated",{"count":345,"type":22},20,[347],"EARLY_PHASE1","A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients\n\nThis study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group.\n\nThe study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine.\n\nA total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.",[28,350,351,352],"Cutaneous Squamous Cell Carcinoma (CSCC)","Actinic Keratosis (AK)","Organ Transplant Recipient",[354,355,264,356,357],"Niacinamide","Cutaneous squamous cell carcinoma","Organ transplant recipient","Actinic keratosis","2026-06-03",{"date":360,"type":41},"2026-06-05",{"date":362,"type":41},"2026-05-01",{"date":364,"type":22},"2027-06-30",{"name":366,"class":48},"Marissa Lobl",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":391,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":49},"100596071","negative-pressure-wound-therapy-for-split-thickness-skin-grafting-to-the-lower-leg-after-excision-of-skin-tumour-a-multicentre-randomised-study-100596071","NCT07040683","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: The Legs Trial - A Multicentre Randomised Study","LEGS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)\n* Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery\n* Ability to provide written informed consent\n* Ability to comply with postoperative instructions and follow-up visits\n\nExclusion Criteria:\n\n* Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers\n* Inability to provide informed consent\n* Severe systemic illness, including:\n* Ongoing sepsis\n* Advanced heart failure\n* End-stage renal or liver disease\n* Active chemotherapy within the previous three months\n* Ongoing treatment with immunosuppressive medications, including:\n* Systemic corticosteroids (e.g., prednisone \\>20 mg\u002Fday or equivalent)\n* Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)\n* Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil)\n* mTOR inhibitors (e.g., sirolimus, everolimus)\n* Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors)\n* Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib)\n* Other immunosuppressive drugs\n* Previous radiation therapy to the surgical site\n* Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)",{"count":376,"type":22},242,[25],"The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are:\n\nDoes NPWT reduce the incidence of transplant infection within three months after STSG?\n\nDoes NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use?\n\nResearchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes.\n\nParticipants will:\n\nUndergo excision of a skin tumour on the lower leg followed by STSG.\n\nBe randomized to receive either NPWT or traditional dressings applied over the graft.\n\nFollow a structured postoperative care and mobilisation schedule.\n\nAttend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.",[380,381,382,383,384,385,386,28,387,388,389,390],"Skin Transplantation","Skin Grafting","Split Thickness Skin Graft","Negative-Pressure Wound Therapy","Postoperative Complications","Surgical Wound Infection","Lower Extremity","Skin Tumour","Wound Healing","Bandages","Leg",[380,381,392,383,384,385,386,388,389,390,393,28],"Split Thickness","Skin Neoplasms","2026-05-27",{"date":396,"type":41},"2026-05-28",{"date":398,"type":41},"2025-11-01",{"date":400,"type":22},"2030-03-31",{"name":402,"class":48},"Region Skane",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":107,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":426,"leadSponsor":428,"locationsCount":49},"100618338","cares--customized-aftercare-report-for-evaluated-skin-cancer-patients-100618338","NCT07330323","CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients","Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening.","CARES","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* Low-risk skin cancer patients:\n\n  1. Negative personal history for melanoma\n  2. Less than 100 naevi\n  3. Less than 5 clinically atypical naevi\n  4. Maximum 1 BCC in history\n  5. Maximum 1 SCC, and at least 5 years ago\n  6. AK: treated and controlled with clinical response\n  7. M Bowen: treated and controlled with clinical response\n* Adult subjects (between 18 years of age and 80 years) at time of enrolment\n\nExclusion Criteria:\n\n* Presence of dermatological lesions requiring immediate treatment at the time of consultation.\n* History of solid organ transplantation (Organ Transplant Recipient, OTR).\n* Known carriers or suspected carriers (based on family history) of germline mutations associated with increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes).\n* Failure to meet one or more of the inclusion criteria.\n* Any condition or comorbidity that, in the opinion of the investigator, may interfere with study participation or data interpretation (e.g. severe cognitive impairment, language barrier).\n* Participation in another interventional clinical trial that may interfere with the outcomes of this study.",{"count":412,"type":22},150,[25],"Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits.\n\nThis project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts .\n\nThe personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.",[416,417,28],"Management","Low Risk",[419,420,421],"Skin cancer risk and management","personalized discharge letter","low-risk skin cancer patients","2026-05-20",{"date":424,"type":41},"2026-05-22",{"date":422,"type":41},{"date":427,"type":22},"2029-06",{"name":429,"class":48},"Universitaire Ziekenhuizen KU Leuven",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":23,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":49},"100553685","mechanisms-for-laser-induced-rejuvenation-100553685","NCT06489301","Mechanisms for Laser-Induced Rejuvenation","Inclusion Criteria:\n\n* Adult males and females 18 and older\n* Able to comprehend procedures and risks\n* Planning to undergo abdominoplasty surgery\n* Minimum amount of skin to be removed is 50 x 20cm\n\nExclusion Criteria:\n\n* Medical history of not well-controlled diabetes. This is defined as a subject who needs high doses of insulin, recent history of hospitalization for diabetes-related complications, or poor wound health as evidenced by diabetic ulcers. Subjects who have been deemed healthy enough for abdominoplasty surgery would tend to suggest that their diabetes should not be an issue. However, if the subjects have diabetic complications as outlined above, they could affect the wound healing which is the object of this protocol so they would be excluded.\n* Pregnant or nursing\n* History of pathologically abnormal wound healing such as keloidal scars\n* Existing tattoos on the abdomen that are so extensive that they could interfere with the study",{"count":437,"type":22},12,[25],"It has shown that laser wounding of geriatric skin protects it against skin cancer. The purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with Fractionated Laser Resurfacing (FLR). These cells restore a youth-like ultraviolet B (UVB) response, but where they come from is currently unknown. The study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.",[28],"2026-05-18",{"date":424,"type":41},{"date":444,"type":41},"2025-07-16",{"date":446,"type":22},"2028-12",{"name":448,"class":48},"Wright State University",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":49},"100499143","phase-2-cryoablationipilimumabnivolumab-in-melanoma-100499143","NCT05779423","Cryoablation+Ipilimumab+Nivolumab in Melanoma","A Phase II Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Advanced Melanoma Receiving Post-progression Dual Immune Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Adult patients (age \\> 18) with unresectable melanoma who have progressed on immune checkpoint inhibitor therapy (pembrolizumab, nivolumab, nivolumab-relatimab, atezolizumab, ipilimumab) and for whom their treating physician plans to initiate dual ICI with ipilimumab and nivolumab. Progression on adjuvant PD-1 inhibition is permitted. PD-1 does not have to be the last therapy received. This is no limited on prior lines of ICI received. There is no wash-out period required from the time of their last therapy.\n* Patients are medically eligible for dual checkpoint inhibition (i.e. no untreated\u002Funcontrolled intercurrent medical issue including ongoing immune-related adverse event or need for systemic steroids \\>10mg PO prednisone or its equivalent, ECOG PS ≤2) with ipilimumab 3mg\u002Fkg and nivolumab 1mg\u002Fkg by their treating physician\n* Must have a tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria.\n* Patients must have measurable disease (by RECIST) independent of the lesion to be ablated. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 (Measurement of Effect) for evaluation of measurable disease.\n* Prior radiation therapy to any site is allowed; with an exception of the target site for planned cryoablation\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Life expectancy of greater than 3 months\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Leukocytes ≥3,000\u002FmcL\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * Total bilirubin ≤3 institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤5 × institutional ULN\n  * CrCL \\> 30 ml\u002Fmin\n* Known Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. (HIV testing not required at screening).\n* For participants with known evidence of known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. (HBV testing not required at screening).\n* Participants with a history of known hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. (HCV testing not required at screening).\n* Participants with asymptomatic brain metastases are eligible.\n* Participants with new or progressive asymptomatic brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Lesion to undergo cryoablation cannot have had prior radiation therapy or other locoregional therapy\n* Inability to hold systemic anticoagulation prior to cryoablation (if holding anticoagulation is required by the operator)\n* Participants who are receiving an investigational agent(s).\n* Participants who are progressing on combination ipilimumab\u002Fnivolumab as their last line of therapy\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1)\n* Patients with symptomatic brain metastasis or LMD\n* Participants on \\> 10mg of oral prednisone or its equivalent\n* Participants with uncontrolled intercurrent illness.\n* Pregnant women are excluded from this study because immune checkpoint inhibitors have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with immune checkpoint inhibitors, breastfeeding should be discontinued.",{"count":457,"type":22},37,[459],"PHASE2","The aim of this study is to find out whether the combination of two approved drugs, ipilimumab and nivolumab, in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant, or is growing, after receiving immunotherapy with a PD-1 inhibitor.\n\nThe names of the study interventions involved in this study are:\n\n* Cryoablation (an interventional radiology procedure that freezes part of a tumor)\n* Ipilimumab (an immunotherapy)\n* Nivolumab (an immunotherapy)",[462,28],"Metastatic Melanoma",[65,462,464,28,465],"Resistant Metastatic Melanoma","Cryoablation","2026-05-15",{"date":468,"type":41},"2026-05-19",{"date":470,"type":41},"2023-09-23",{"date":472,"type":22},"2028-01-01",{"name":474,"class":48},"Massachusetts General Hospital",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":49},"100567833","phase-1-brodalumab-in-the-treatment-of-immune-related-adverse-events-100567833","NCT06673329","Brodalumab in the Treatment of Immune-Related Adverse Events","Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study","Inclusion Criteria:\n\n* Ability to provide written informed consent by subject or guardian\n* Individuals \\>18 years of age\n* Diagnosis of an irAE clinically suspected to be IL-17 mediated\n* Intent-to-treat or prior treatment with systemic steroids for irAE management\n* Histology-proven primary advanced or metastatic solid organ malignancy treated with immunotherapy. Patients being treated with curative intent are not eligible to enroll.\n* Subject has a negative test for tuberculosis during screening defined as either: negative purified protein derivative (PPD) (\\\u003C 5 mm of induration at 48 to 72 hours after test is placed) OR negative QuantiFERON test. Tuberculosis testing must be performed within 30 days prior to trial initiation.\n* Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative QuantiFERON test.\n* Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate QuantiFERON test are allowed if they have all of the following: no symptoms of tuberculosis (defined as fever, shortness of breath, cough or night sweats), documented history of a completed course of adequate prophylaxis (per local standard of care), no known exposure to a case of active tuberculosis after most recent prophylaxis, no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of brodalumab.\n\nExclusion Criteria:\n\n* Estimated creatinine clearance \\\u003C 40 mg\u002Fmin\n* Active suicidal ideation or severe depression (as defined by the Diagnostic and Statistical Manual of Mental Disorders Version IV criteria (DSM-IV)) at the time of enrollment or a PHQ-9 score \\> 20\n* History of prior suicide attempts\n* PHQ-9 score greater \\>5 and \\\u003C 20 without an established mental health provider who verifies stability in their depression\n* Current or prior drug or alcohol abuse within the past 6 months (as defined by the DSM IV)\n* In the opinion of the investigator, the patient requires additional immunosuppressive treatment (other than corticosteroids and brodalumab)\n* Known hypersensitivity or contraindication to brodalumab, corticosteroids or any components of brodalumab\n* Prior treatment with brodalumab\n* Pregnancy, breastfeeding, or use of a nonreliable method of contraception\n\n  * For patients assigned female at birth: lack of willingness to use highly effective methods of birth control during treatment and for at least 4 weeks after the last dose of brodalumab (except if surgically sterile or at least 2 years postmenopausal, with postmenopausal status confirmed by Follicle-Stimulating Hormone (FSH) in the postmenopausal range).\n  * Highly effective methods of birth control include: use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Oral contraceptive pills must be supplemented by a barrier method.\n  * Patients planning to become pregnant while enrolled in the study and within 4 weeks after the last dose of brodalumab will not be permitted to enroll\n* Chronic or current severe infection requiring IV therapy\n* Evidence of active hepatitis B, C, or tuberculosis.\n* History of latent tuberculosis infection which is incompletely treated based upon local standard of care or which was never treated\n* History of or active Crohn's disease.\n* Myocardial infarction, unstable angina pectoris or stroke within the past 12 months prior to the first investigational product dose\n* Any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.\n* Any medical condition or treatment for a condition that, in the opinion of the investigator, might interfere with participation in the study or affect the reliability of clinician assessment or patient self-report\n* Other known clinically significant active medical conditions, such as:\n\n  * Severe cardiovascular disease, including advanced heart failure (American Heart Association Stage D)\n  * Aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal or greater than 3 times the upper limit of normal in patients with liver metastases measured on at least two separate occasions\n  * Direct bilirubin greater than or equal to 1.5 mg\u002FdL in patients with or without liver metastases\n  * Bone marrow insufficiency unrelated to the irAE (according to investigator judgment) with White Blood Cell (WBC) \\\u003C2000\u002Fmm3, absolute neutrophil count \\\u003C1500\u002F mm3, thrombocytopenia (platelet count) \\\u003C50,000\u002Fmm3, hemoglobin \\\u003C 8.0 g\u002FdL\n* Plan to proceed with further curative intent treatment for cancer at the time of enrollment despite the presence of irAE\n* Participation in another therapeutic clinical trial and receipt of investigational drugs within 4 weeks before the screening visit\n* Previous diagnosis of an autoimmune disease or administration of immunosuppressants in a time frame that would impede interpretation of brodalumab administration\n* Planned use of immunosuppressive agents other than steroids (including infliximab, vedolizumab, tocilizumab etc.) or administration of such agents within 28 days of trial initiation\n* Administration of live-virus vaccines within 4 weeks before the first dose of brodalumab",{"count":220,"type":22},[484],"PHASE1","The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.",[144,113,74,112,111,487,110,488,489,115,116,73,490,75,28,128,129,491],"Gynecologic Cancer","Stomach Cancer","Brain Tumor","Oral Cancer","Solid Tumor","2026-05-11",{"date":494,"type":41},"2026-05-13",{"date":496,"type":41},"2025-03-11",{"date":498,"type":22},"2027-11",{"name":500,"class":48},"Brian Henick, MD",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":528},"100494213","adaptive-symptom-self-management-immunotherapy-study-100494213","NCT05715255","Adaptive Symptom Self-Management Immunotherapy Study","Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age 18 or older\n* Within 12 weeks after starting ICI treatment for cancer\n* Cognitively oriented to person, place and time (determined by recruiter)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library\n\nExclusion Criteria:\n\n* Currently receiving regular behavioral counseling",{"count":509,"type":22},400,[25],"The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers (HCPs) may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services.",[144,115,112,28,513],"Rectum Cancer",[64,515,65,516,517,518,519],"Cancer Survivors","Immune Checkpoint Inhibitors","Symptom Management","Psychosocial Oncology","Telephone Intervention",{"date":521,"type":41},"2026-05-14",{"date":523,"type":41},"2023-05-08",{"date":525,"type":22},"2027-04-30",{"name":527,"class":48},"University of Arizona",3,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":49},"100545670","raman-spectroscopy-and-skin-cancer-100545670","NCT06384924","Raman Spectroscopy and Skin Cancer","Pilot Study of Raman Spectroscopic Imaging for Skin Cancer","Inclusion Criteria:\n\n* Histologically confirmed skin cancer (either basal cell carcinoma or squamous cell carcinoma)\n* Participants must plan to receive brachytherapy treatment for the skin cancer at the study site.\n* Ability to provide consent to the study.\n\nExclusion Criteria:\n\n* Patient belongs to a vulnerable population (Minors (under 18 years old), Adults unable to consent, prisoners).\n* Lesions on the eyelid or in close proximity to the eye\n* Pregnant women, or women of childbearing age who refuse pregnancy testing.\n* Patient has pacemaker.",{"count":345,"type":22},"The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:\n\n-Can Raman Spectroscopy help figure out how far a tumor spreads?\n\nThis study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin.",[28,292,207],"2026-04-30",{"date":541,"type":41},"2026-05-07",{"date":543,"type":41},"2025-02-13",{"date":545,"type":22},"2027-02-13",{"name":547,"class":48},"Tiezhi Zhang",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":574,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":587},"100543937","phase-1-a-study-of-oral-7hp349-alintegimod-in-combination-with-ipilimumab-followed-by-nivolumab-monotherapy-100543937","NCT06362369","A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy","A Phase 1b\u002F2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies","Inclusion and Exclusion Criteria for Phase 1b\n\nInclusion Criteria\n\n1. Adult patients (age 18 or older)\n2. Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1\u002FPD-L1.\n3. ANC ≥ 1000\u002FµL without use of G-CSF, Hgb ≥ 9 g\u002FdL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000\u002FµL without transfusions for at least 5 days prior to pretreatment baseline.\n4. ECOG performance status of 0 or 1.\n5. Has a life expectancy of \\> 12 weeks.\n6. Renal and hepatic function requirements:\n\n   * a. Renal function with either an eCrCL ≥ 60 mL\u002Fmin (modified Cockcroft-Gault) or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (using MDRD or CKD-EPI or similar equations).\n   * b. Hepatic function with ALT\u002FAST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST\u002FALT≤ 5 x ULN will be allowed.\n7. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n8. All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).\n9. All patients must have measurable disease by applicable RECIST criteria.\n10. Willing to allow blood samples to be used for research.\n\nExclusion Criteria:\n\n1. Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \\\u003C 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.\n2. Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.\n3. Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.\n4. Persistent toxicity of NCI CTCAE version 5 Grade \\> 1 severity that is related to prior therapy.\n\n   Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior treatments that are controlled with medication (e.g., diabetes or hypertension) are permitted.\n5. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates; consider a dose reduction of such substrates and monitor for signs of toxicities of co-administered sensitive CYP3A substrates (see listing of strong inhibitors and inducer drugs in FDA tables). An alternative is to replace such agents with drugs that are not CYP3A4 metabolized if at all feasible.\n6. The patient has cardiac conditions as follows:\n\n   * a) myocarditis;\n   * b) uncontrolled hypertension (blood pressure \\> 160\u002F100) despite optimal therapy;\n   * c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);\n   * d) prior or current cardiomyopathy;\n   * e) uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);\n   * f) concomitant medication with drugs known to cause Torsades de Pointes;87\n   * g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \\[ECG\\]) at screening.\n7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).\n8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n9. Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or Women, not otherwise meeting other exclusion criteria, who are WOCBP must be on contraception for a minimum duration of 3 months prior to treatment and continue contraception during treatment and for 5 half-lives after the last dose of the investigational drug.\n10. The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n11. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:\n\n    * a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;\n    * b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg\u002Fday of prednisone or equivalent.\n    * c) Corticosteroid premedication for infusion and\u002For hypersensitivity reactions.\n    * d) Patients may be treated with a short (\\\u003C24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents.\n12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.\n13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study\n14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted.\n15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least.\n16. Use of mechanical ventilation or having a resting O2 saturation \\\u003C 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and\u002For severe hepatic sinusoidal obstruction syndrome.\n17. Proven or suspected ongoing systemic infection requiring IV antibiotics.\n18. Women who are pregnant or lactating.\n\n    Note: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the following:\n    * a) Postmenopausal with \\> 1 year since last menses and:\n    * 1\\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \\> 40 mIU\u002FmL.\n    * 2\\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \\> 30 mIU\u002FmL.\n    * 3\\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).\n    * b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).\n\n    Note: Tubal ligation is not considered a form of permanent sterilization.\n19. Psychiatric illness\u002Fsocial circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.\n20. Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed\n21. Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1).\n\n    Note: Patients who switch from a high dose to a dose of ≤30 µg\u002Fday are eligible for study entry.\n22. Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.\n23. Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral drug absorption.\n24. Patients with known soy allergy.",{"count":556,"type":22},126,[484,459],"This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.\n\nCurrently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b",[560,561,146,562,563,564,565,566,69,567,568,569,74,28,570,571,572,573],"Advanced Cancer","Advanced Solid Tumor","Metastasis","Pleural Mesothelioma","Renal Cell Carcinoma","MSI-High","Mismatch Repair Deficiency","Hepatocellular Carcinoma","Hepatocellular Cancer","Renal Cell Cancer","Non Small Cell Lung Cancer","NSCLC","Anaplastic Lymphoma Kinase Genomic Tumor Aberrations","ALK Genomic Tumor Aberrations",[575,576,577],"Phase 1","Phase 1b","7 Hills Pharma","2026-04-07",{"date":580,"type":41},"2026-04-13",{"date":582,"type":41},"2024-08-23",{"date":584,"type":22},"2028-12-31",{"name":586,"class":94},"7 Hills Pharma, LLC",5,{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":528},"100442877","alpha-radiation-emitters-device-dart-in-combination-with-check-point-inhibitor-for-the-treatment-of-recurrent-unresectable-or-mhnscc-100442877","NCT05047094","Alpha Radiation Emitters Device (DaRT) in Combination With Check Point Inhibitor for the Treatment of Recurrent Unresectable or mHNSCC","A Safety and Efficacy Study of Intratumoral Diffusing Alpha Radiation Emitters in Recurrent Unresectable or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Pathologically confirmed, metastatic, or recurrent unresectable squamous cell carcinoma of the head and neck.\n2. Ability to provide tissue sample, either from an archive or undergo another biopsy to provide a fresh sample\n3. Targetable lesion must be technically amenable for the DaRT seeds implantation\n4. Brachytherapy indication validated by a multidisciplinary team\n5. Targetable lesion according to RECIST v1.1\n6. Age ≥ 18 years old\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale ≤ 2\n8. Subjects' life expectancy is more than 6 months\n9. White Blood Count (WBC) ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n10. Platelet count ≥ 100,000\u002Fµl\n11. Hemoglobin ≥ 9 g\u002Fdl\n12. Calculated or measured creatinine clearance ≥ 60 cc\u002Fmin\n13. Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 X Upper Limit of Normal (ULN) or ≤ 5 X ULN for subjects with liver metastases\n14. International normalized ratio (INR) \\\u003C1.4 for patients not on Warfarin\n15. Subjects are willing and able to sign an informed consent form\n16. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n\nExclusion Criteria:\n\n1. Previous treatment for metastatic disease (for recurrent unresectable disease, previous treatment is allowed given that 6 months had elapsed from completion of treatment for primary disease)\n2. Patients with brain metastases\n3. Combined Positive Scores (CPS) \\\u003C1\n4. Patients with known contraindications to radiotherapy\n5. Any prior therapy with anti-PD-L1 (Programmed death-ligand), anti-PD-L2, anti-CTLA-4 (Cytotoxic T lymphocyte antigen) antibody, etc.\n6. Any history of a sever hypersensitivity reaction to any monoclonal antibody.\n7. Known hypersensitivity to any of the components of the DaRT.\n8. Has a known history of active TB (Tuberculosis Bacillus )\n9. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n10. Any diagnosis of immunodeficiency or current immunosuppressive therapy including \\>10mg\u002Fday of prednisone within 14 days of enrollment is not permitted\n11. Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n12. Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n13. Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n14. Has a known history of Human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n15. Has known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected)\n16. Pregnancy or lactation.\n17. Patients must agree to use adequate contraception (abstinence, barrier method of birth control, or any other medically acceptable form of contraception) prior to study entry, for the duration of study participation and for 6 months after last dose of Pembrolizumab.",{"count":596,"type":22},48,[25],"A unique combinational treatment for cancer employing intratumoral diffusing alpha radiation emitter device with check point inhibitor for recurrent unresectable or metastatic Head and Neck Squamous Cell Carcinoma",[600,28,601],"Head and Neck Squamous Cell Carcinoma","Metastatic Head-and-neck Squamous-cell Carcinoma",[207,260,28,261,262,210,603,267,211,604,605,606,607],"Recurrent disease","Pembrolizumab","Check Point Inhibitor","KEYTRUDA","Immunomodulators","2026-03-31",{"date":610,"type":41},"2026-04-06",{"date":612,"type":41},"2021-11-02",{"date":614,"type":22},"2027-06",{"name":219,"class":94},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":17,"sex":18,"minAge":58,"maxAge":624,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":626,"briefSummary":627,"conditions":628,"keywords":634,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":652,"leadSponsor":653,"locationsCount":244},"100632159","title-icarus---psycho-physiological-profiling-of-low-and-high-heat-resilient-individuals-100632159","NCT07510061","Title: ICARUS - Psycho-physiological Profiling of Low and High Heat-resilient Individuals","Physiological Phenotyping","ICARUS","Study Population\n\nHealthy adult volunteers residing in Denmark (Northern Europe) or Greece (Southern Europe).\n\nInclusion Criteria\n\n* Age 18-65 years (or your protocol-specific age range)\n* Healthy as determined by medical history screening questionnaire\n* Able to provide written informed consent\n* Able to complete heat exposure and light exercise protocol\n* No heat acclimatization or extensive sun exposure in the previous 4 weeks\n* Fitzpatrick skin type I-IV (if applicable for UV testing)\n* Willing to undergo blood sampling, urine collection, and skin biopsy\n\nExclusion Criteria\n\n* History of cardiovascular, metabolic, neurological, or dermatological disease\n* History of heat-related illness (e.g., heat stroke)\n* Use of medications affecting thermoregulation or cardiovascular function\n* Smoking or substance abuse\n* Pregnancy or breastfeeding\n* Abnormal ECG or uncontrolled hypertension\n* Recent severe sunburn or UV treatment\n* Contraindications to skin biopsy\n* Inability to tolerate heat exposure during screening","65 Years",{"count":285,"type":22},[25],"The escalating environmental heat-stress associated with global warming is a societal challenge with large and potential harmful consequences for humans. Excess morbidity and mortality during heat waves provides strong evidence for fatal outcomes. However, it is unclear why some people are particularly vulnerable and get sick from hyperthermia, while others adapt and tolerate exposure.\n\nThe Icarus project aims to provide a psycho-physiological framework for improved mitigation of the health threats associated with global warming. Combining expertise in integrative thermal physiology, pharmacology, photobiology, psychology and machine learning, we will collaborate on comprehensive cross-scientific studies using controlled lab-exposure combined with investigations in ecological settings including vulnerable and highly tolerant people across populations from northern to southern Europe.\n\nAdvanced algorithms will be developed to generate personalized alerts and advising based on behavioral patterns, psychological profiling, predicted vulnerability and willingness to adopt resilience-building strategies.\n\nGlobal warming is projected to continue towards the end of the 21st century and constitutes an increasing threat to human health unless we as individuals and collectively become better in preventing acute effects, as well as devise sustainable strategies to limit further anthropogenic warming of the climate system. Acutely, improved guidance is important for both individual and public health, where Icarus aims at providing a highly improved basis for preventing heat-related disease, advising or nudging people towards pro-health behavior, including smarter use of technologies to mitigate heat stress, or adjusting medication to reduce adverse effects during heat events. In support of the sustainability agenda, our framework also forms a novel basis for developing advising algorithms relevant for optimization of climate change mitigation policy-making.",[28,629,630,631,632,633],"Heat Tolerance","Heat-related Illness","Hyperthermia","Heat Stress","Ultraviolet Radiation-Related Skin Damage",[632,635,636,637,631,638,639,640,641,642,643,644,645,646,647],"Heat-Related Illness","Heat Vulnerability","Heat Intolerance","Environmental Heat Exposure","Thermal Stress","Ultraviolet Radiation Exposure","Skin DNA Damage","Cardiovascular Strain (Heat-Induced)","Cognitive Impairment (Heat-Induced)","Occupational Heat Stress","Climate Change and Health","Heat Resilience","Heat Acclimatization","2026-03-27",{"date":650,"type":41},"2026-04-03",{"date":398,"type":41},{"date":525,"type":22},{"name":654,"class":48},"University of Thessaly",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":662,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":665,"briefSummary":666,"conditions":667,"keywords":671,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":587},"100619847","early-detection-of-skin-tumors-using-a-telemedicine-tool-in-primary-care-100619847","NCT07349940","Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care","MEL","Inclusion Criteria:\n\n* at least 1 suspected lession\n* phototype I or phototype II\n\nExclusion Criteria:\n\n* skin lession examination by dermatologist in last 12 months\n* unsigned consent to participate in the project and consent to the processing of personal data","50 Years",{"count":664,"type":22},1440,[25],"The project is a national, prospective, multicenter, single-arm interventional pilot of screening skin tumors in the Czech Republic.\n\nThe primary aim of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of skin tumors by using a telemedicine tools and setting up and testing new methods and implementation into the system of social health care.",[29,668,669,28,670],"Melanoma In Situ","Skin Lesions","Mole (Dermatology)",[32,672,673,674],"melanoma","telemedicine tool","skin tumors","2026-03-25",{"date":648,"type":41},{"date":678,"type":41},"2026-02-01",{"date":680,"type":22},"2026-09-30",{"name":682,"class":683},"Institute of Health Information and Statistics of the Czech Republic","OTHER_GOV",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":23,"phases":693,"briefSummary":694,"conditions":695,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":49},"100493226","early-phase-1-pilot-trial-of-supplemental-vitamin-a-and-nicotinamide-100493226","NCT05702398","Pilot Trial of Supplemental Vitamin A and Nicotinamide","Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide","Inclusion Criteria:\n\n* 18 years old or greater;\n* Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or\n* At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);\n* Understands, reads, and writes English proficiently.\n\nExclusion Criteria:\n\n* Liver disease;\n* Active peptic ulcer disease;\n* Recent myocardial infarction;\n* Hypotension;\n* Internal malignancy within past 5 years;\n* Renal impairment with eGFR\\\u003C15 mL\u002Fmin\u002F1.73 m2;\n* Being unable for follow up due to social reasons;\n* Gorlin's syndrome or other genetic skin cancer syndrome;\n* Huge number of current skin cancers;\n* Metastatic SCC or invasive melanoma within the past 5 years;\n* Pregnancy or lactation;\n* Need for ongoing carbamazepine use (which could have a possible interaction with NAM);\n* Use of acitretin or other oral retinoids within the past 6 months;\n* Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;\n* Field treatment for actinic keratoses (AKs) within the previous 4 weeks;\n* Use of topical steroids.",{"count":692,"type":22},30,[347],"The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \\[niacin\\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.",[28,696],"Kidney Transplant Recipients","2026-03-18",{"date":699,"type":41},"2026-03-20",{"date":701,"type":41},"2023-04-01",{"date":703,"type":22},"2028-03-01",{"name":705,"class":48},"Rhode Island Hospital",{"id":707,"slug":708,"hasResults":12,"nctId":709,"briefTitle":710,"officialTitle":711,"acronym":712,"eligibilityCriteria":713,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":714,"targetDuration":4,"studyType":23,"phases":715,"briefSummary":716,"conditions":717,"keywords":722,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":724,"lastUpdatePostDateStruct":725,"startDateStruct":727,"completionDateStruct":729,"leadSponsor":731,"locationsCount":528},"100587260","phase-1-early-phase-study-of-kesonotidein-participants-with-solid-tumours-100587260","NCT06926075","Early Phase Study of KESONOTIDE™in Participants With Solid Tumours","An Adaptive Phase I\u002FII Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours","ADVICE","Inclusion Criteria:\n\n* Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).\n* Has an ECOG performance status score of 0 or 1.\n* Has a life expectancy of \\> 12 weeks in the opinion of the investigator.\n* Measurable or evaluable disease by CT\u002FMRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.\n* Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid cancers.\n* Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:\n* Laboratory Value\n* Hematology\n* Platelet count \\> 100 x 109\u002FL\n* Hb \\> 9.0 g\u002FdL\n* ANC \\> 1.5 x 109\u002FL\n* Renal Function\n* Creatinine \\\u003C 1.5 x ULN\n* Hepatic Function\n* AST and ALT \\\u003C 3 x ULN for the reference laboratory or \\\u003C 5 x ULN in the presence of liver metastases\n* Total bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 2.5 g\u002FdL\n* INR\u002FPT and APTT ≤ 1.5 x ULN\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.\n* Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).\n\nAdditional Inclusion Criteria for Parts 2 and 3:\n\n* Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).\n* Defined diseases or disease states of interest, suitable for dose expansion.\n* Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.\n\nExclusion Criteria:\n\n* Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.\n* Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.\n* Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.\n* A clinically significant active infection determined by the investigator.\n* Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.\n* Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.\n* Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.\n* Has a history or presence of uncontrolled mental illness.\n* The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.\n* Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.\n\nAdditional Exclusion Criteria for Parts 2 and 3:\n\n\\- Patients must not have more than 2 prior lines of therapy.",{"count":285,"type":22},[484,459],"This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers.\n\nIt is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II.\n\nPrimary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced\u002Fmetastatic solid cancers.\n\nSecondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.",[718,144,719,150,720,721,28],"Prostate Cancers","Lung Cancers","Glioblastoma Multiforme (GBM)","Pancreas Cancer",[723],"kesonotide, vimentin inhibotor","2026-03-15",{"date":726,"type":41},"2026-03-17",{"date":728,"type":41},"2025-11-07",{"date":730,"type":22},"2027-10-26",{"name":732,"class":94},"Filamon LTD",{"id":734,"slug":735,"hasResults":12,"nctId":736,"briefTitle":737,"officialTitle":738,"acronym":4,"eligibilityCriteria":739,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":4,"enrollmentInfo":740,"targetDuration":4,"studyType":23,"phases":741,"briefSummary":743,"conditions":744,"keywords":746,"overallStatus":755,"whyStopped":4,"lastUpdateSubmitDate":756,"lastUpdatePostDateStruct":757,"startDateStruct":759,"completionDateStruct":761,"leadSponsor":763,"locationsCount":244},"100625734","phase-4-cosibelimab-for-cscc-in-patients-with-kidney-transplant-or-hematologic-malignancy-100625734","NCT07426484","Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy","A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)","Inclusion Criteria:\n\n* COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.)\n* COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM).\n* Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to:\n\n  * Chronic lymphocytic leukemia (CLL)\n  * Small cell lymphocytic lymphoma (SLL)\n  * Follicular lymphoma (FL)\n  * Lymphoplasmacytic lymphoma\n  * Waldenström macroglobulinemia\n  * Marginal zone lymphoma\n  * Mantle cell lymphoma, indolent variety\n  * Cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome)\n* Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to:\n\n  * Chronic myelogenous leukemia (CML)\n  * Polycythemia vera (PV)\n  * Primary myelofibrosis\n  * Essential thrombocythemia (ET)\n  * Chronic neutrophilic leukemia\n  * Chronic eosinophilic leukemia\n* Examples of myeloma, including but not limited to:\n\n  * Multiple myeloma (MM)\n  * Smoldering myeloma\n* Participants must have histologically or cytologically confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC).\n* Note: Mixed histology is acceptable (e.g. basosquamous, squamous cell carcinoma with adnexal differentiation), and other histologic variants (sarcomatoid carcinoma, spindle cell carcinoma, poorly differentiated carcinoma with squamous features).\n* Participant must have CSCC that is not amenable to surgery or radiation therapy, or recurrent despite prior surgery or radiation therapy, including locally advanced unresectable CSCC for which local therapy (surgery and\u002For radiation therapy) is not recommended. This includes CSCC occurring in patients who are not surgical candidates due to comorbidities and patients who refuse surgery (due to concerns about morbidity, disfigurement, etc).\n* Participants must have measurable disease as per PET Response Criteria in Solid Tumors version\n* (PERCIST 1.0),46 defined as any tumor (of any size) whose SUV lean (SUL) peak is greater than 1.5 times the mean SUL in the liver + 2 times its standard deviation. Mean SUL in the liver is measured in a 3-cm diameter spherical volume of interest (VOI), which is a measurement of the SUV background.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of cosibelimab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0-2 (see Appendix A for definitions of this and Karnofsky Performance Status).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1.0 K\u002FmcL\n  * Platelets ≥30 K\u002FmcL\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL\n  * AST(SGOT) ≤ 2.5 × institutional ULN\n  * ALT(SGPT) ≤ 2.5 × institutional ULN\n  * Adequate renal function, defined as defined as estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\n  * Serum creatinine ≤ 3.0 x institutional ULN or ≤ 3.0 x baseline (grade ≤ 2 per CTCAE)\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* PD-1 and PD-L1 immune checkpoint antibodies are classified as pregnancy class D. For this reason, and because other therapeutic agents used in this trial are potentially teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and 120 days after completion of cosibelimab administration. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 120 days after completion of cosibelimab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.\n* Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)\n* Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.\n* Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone \\>10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).\n* Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.\n* Participants who are receiving any other investigational agents for cancer within 2 weeks of study enrollment.\n* Participants who have uncontrolled, symptomatic infections, or infections requiring systemic antibiotics (prophylactic antimicrobials are permitted).\n* Participants who have uncontrolled or unstable brain metastases (or other CNS metastases) for whom systemic steroids are required. These patients are excluded because steroids may interfere with the effectiveness of immune checkpoint therapy.\n* Uncontrolled or significant cardiovascular disease.\n* Current need for dialysis (hemodialysis or peritoneal dialysis).\n* History of stem cell transplant or bone marrow transplant\n* Psychiatric illness or social situation that would preclude study compliance.\n* Pregnant and breastfeeding women are excluded from this study because cosibelimab is classified as pregnancy class D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cosibelimab, breastfeeding should be discontinued if the mother is treated with cosibelimab.\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study drug are excluded.\n* COHORT A ONLY:\n\n  * History of organ transplant other than kidney, including a heart, lung, or liver transplant, etc, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.\n  * History of severe allergic reaction attributed to sirolimus or everolimus, or other absolute contraindication to mTOR inhibitor, as determined by the treating physician.\n* COHORT B ONLY: History of any solid organ transplant, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.",{"count":285,"type":22},[742],"PHASE4","This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC).\n\nThe name of the drug involved in this research study is:\n\n-cosibelimab (a type of an anti-PD-L1 antibody)",[745,28],"Cutaneous Squamous Cell Carcinoma",[747,745,28,748,749,750,751,752,753,754],"Advanced Cutaneous Squamous Cell Carcinoma","Kidney Transplant Recipient","Chronic lymphocytic leukemia (CLL)","Myeloma","Waldenstrom macroglobulinemia","Solid Organ Transplant Recipient","Immunosuppressed","Lymphoma","NOT_YET_RECRUITING","2026-02-20",{"date":758,"type":41},"2026-02-23",{"date":760,"type":22},"2026-07",{"date":762,"type":22},"2032-12-15",{"name":764,"class":48},"Dana-Farber Cancer Institute",{"id":766,"slug":767,"hasResults":12,"nctId":768,"briefTitle":769,"officialTitle":770,"acronym":4,"eligibilityCriteria":771,"healthyVolunteers":12,"sex":18,"minAge":58,"maxAge":772,"enrollmentInfo":773,"targetDuration":4,"studyType":23,"phases":775,"briefSummary":776,"conditions":777,"keywords":784,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":790,"lastUpdatePostDateStruct":791,"startDateStruct":792,"completionDateStruct":794,"leadSponsor":796,"locationsCount":49},"100596191","the-florida-ascent-study-100596191","NCT07042243","The Florida ASCENT Study","The Florida Partnership for Adding Social Context to Address Cancer Survivorship Outcomes (Florida ASCENT)","Patient Eligibility Inclusion Criteria:\n\n1. ≥18 years old.\n2. Pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months.\n3. Self-reported ability to read and speak English.\n4. Able to provide informed consent.\n5. Participant must not be considered a \"vulnerable population\" (pregnant women, neonates, children etc.)\n\nPatient Eligibility Exclusion Criteria:\n\n1. ≤18 years old.\n2. Participant do not have a pathologically confirmed diagnosis of colorectal, prostate, lung, breast, gynecologic, hematologic, or skin (including melanoma) cancer within the past 12 months.\n3. Participant does not live within the state of Florida.\n\n3\\) Does not self-reported ability to read and speak English or Spanish. 4) Not able to provide informed consent. 5) Participant is considered a \"vulnerable population\" (pregnant women, neonates, children etc.)\n\nProvider Eligibility Inclusion Criteria\n\n1. ≥18 years old.\n2. Currently works as a physician, physician assistant, patient navigator and\u002For health system\u002Fadministrative leader in UF and UM affiliated clinics.\n3. Self-reported ability to read and speak English or Spanish.\n4. Able to provide informed consent.\n5. Participant must not be considered a \"vulnerable population\" (pregnant women, neonates, children etc.)\n\nProvider Eligibility Exclusion Criteria\n\n1. ≤ 18 years old.\n2. Does not currently works as a physician, physician assistant, patient navigator and\u002For health system\u002Fadministrative leader in UF and UM affiliated clinics.\n3. Does not self-report having the ability to read and speak English.\n4. Not able to provide informed consent.\n5. Participant is considered a \"vulnerable population\" (pregnant women, neonates, children etc.)","100 Years",{"count":774,"type":22},100,[25],"The goal of this clinical trial is to adapt, implement, and evaluate MyCarePulse and ASCENT patient navigator to overcome barriers to care among patients with cancer.\n\nThe main hypotheses it aims to test are:\n\n* At the patient level, the intervention will result in higher levels of food security, self- efficacy for dietary behaviors, and higher diet quality than standard care.\n* At the provider level, the intervention will be feasible, acceptable, appropriate, and able to enhance individualized care for patient wellness.\n\nResearchers will compare cancer patients receiving the MyCarePulse and ASCENT patient navigator intervention to those receiving standard care, to see if the intervention improves food security, self-efficacy, and diet quality.\n\nPhase 1\n\nPatient Participants will:\n\n* Complete the ASCENT Questionnaire, which is comprised of the following:\n\n  * U.S. Food Security Survey Module (U.S. FSSM)\n  * Patient-Reported Outcomes Measurement Information System (PROMIS-29)\n  * Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool\n* Be assessed using the Veggie Meter instrument\n* Participate in two semi-structured interviews\n\nProvider Participants will:\n\n•Participate in one semi-structured interview\n\nPhase 2\n\nPatient Participants will:\n\n* Participate in ASCENT patient navigator screenings and consultations\n* Complete the ASCENT Questionnaire, which comprises the U.S. FSSM, PROMIS-29, and ASA24®",[64,778,779,780,69,128,112,144,487,781,28,146,782,783],"Food Deprivation","Food Habits","Food Selection","Hematologic Cancer","Nutrition Poor","Nutritional Deficiency",[785,64,786,787,788,789],"Food Insecurity","Food Access","Community-Informed Research","Nutritional Needs","Mixed-Methods","2026-02-19",{"date":756,"type":41},{"date":793,"type":41},"2025-12-05",{"date":795,"type":22},"2027-08",{"name":797,"class":48},"University of Florida"]