[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"basal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:basal-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,47,80,115,135,183,223,243,260,280,313,336,377,404,437,455,540,573,593,623,660,680,700,725],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645016","ai-based-risk-classification-and-histopathological-subtype-prediction-of-basal-cell-carcinoma-using-dermoscopic-images-100645016",false,"NCT07677124","AI-Based Risk Classification and Histopathological Subtype Prediction of Basal Cell Carcinoma Using Dermoscopic Images","Risk Classification and Prediction of Histopathological Subtypes in Basal Cell Carcinoma Using a CNN-Based Artificial Intelligence Model on Dermoscopic Images","BCC-AI","Inclusion Criteria:\n\n* Patients with histopathologically confirmed basal cell carcinoma.\n* Cases with a specified histopathological subtype.\n* Availability of dermoscopic images with sufficient image quality and resolution for artificial intelligence analysis.\n\nExclusion Criteria:\n\n* Cases without histopathological confirmation of basal cell carcinoma.\n* Cases with unspecified histopathological subtype.\n* Images with insufficient quality or resolution for artificial intelligence analysis.\n* Cases without available dermoscopic images.","ALL","0 Years","100 Years",{"count":21,"type":22},2500,"ESTIMATED","OBSERVATIONAL","This retrospective observational study aims to develop and evaluate a convolutional neural network (CNN)-based artificial intelligence model for risk classification and histopathological subtype prediction of basal cell carcinoma (BCC) using clinical and dermoscopic images. Histopathologically confirmed BCC cases from a dermatology archive will be included. The primary objective is to assess the diagnostic performance of the CNN model in classifying BCC as low-risk or high-risk. Secondary objectives include predicting histopathological subtypes and comparing the model's performance with that of dermatology physicians. Histopathological diagnosis will serve as the reference standard. All archived data will be anonymized before analysis.",[26],"Basal Cell Carcinoma",[26,28,29,30,31,32,33],"Artificial Intelligence","Convolutional Neural Network","Dermoscopy","Skin Cancer","Histopathological Subtypes","Risk Classification","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2026-05-22",{"date":42,"type":22},"2027-05-22",{"name":44,"class":45},"Istanbul Training and Research Hospital","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"100611515","vitamin-d-effects-on-immune-microenvironment-of-nonmelanoma-skin-cancer-after-photodynamic-therapy-pdt-100611515","NCT07241585","Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT)","Inclusion Criteria:\n\n* Must be an adult participant (\\> 18 yrs) who is scheduled to undergo Mohs surgery or ED\\&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.\n* Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery.\n* The original tumor size prior to biopsy must be \\>1.0 cm (in the longest diameter).\n* Participants of any ethnic group are eligible for this trial.\n* Must provide informed consent to participate in the trial.\n* Participant must live in Ohio (Groups 2 \\& 3), because Research Pharmacy cannot ship the study drugs outside of the state.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Currently being treated for other cancers with medical or radiation therapy\n* Known hypersensitivity to 5-aminolevulinic acid\n* History of a photosensitivity disease, e.g., porphyria cutanea tarda","18 Years",{"count":55,"type":22},54,"INTERVENTIONAL",[58],"NA","This research study is for people who have been diagnosed with a nonmelanoma skin cancer (either basal cell carcinoma or squamous cell carcinoma) and are planning to receive either Mohs surgery or ED\\&C (electrodessication \\& curettage) as part of clinical care. The purpose of this study is to understand how photodynamic therapy (PDT) with or without Vitamin D can promote an immune response to skin cancer.\n\nFor this study, participants will be randomized (randomly assigned) and asked to take Vitamin D or placebo for 6 days and come to the clinic for a single PDT treatment 1-14 days prior to their surgery. At this visit, photographs of participant's skin cancer will be taken, and participants will undergo PDT treatment. The study team will also take photos on the day of Mohs surgery or ED\\&C. There will be up to two blood draws for research.\n\nIf participants do not want to come in for a PDT treatment prior to their Mohs surgery or ED\\&C, they will have the option to participate by only allowing the study team to collect data about their skin cancer and their tissue from Mohs surgery or ED\\&C.",[61,26,62],"Nonmelanoma Skin Cancer","Squamous Cell Carcinoma",[64,65,66,67,68,69],"Mohs surgery","Electrodessication & curettage","ED&C","Photodynamic therapy","PDT","Vitamin D","2026-06-17",{"date":72,"type":38},"2026-06-18",{"date":74,"type":38},"2026-02-25",{"date":76,"type":22},"2027-08",{"name":78,"class":79},"Case Comprehensive Cancer Center","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":46},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":88,"type":22},25,[90],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[93,26,62,94,95,96,97,98,99,100,101,102,103,104,105],"Adenocarcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":108,"type":38},"2026-06-05",{"date":110,"type":38},"2026-05-01",{"date":112,"type":22},"2028-05-01",{"name":114,"class":79},"University of California, Irvine",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":56,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":46},"100606952","pilot-study-of-line-field-confocal-optical-coherence-tomography-for-detection-of-mohs-micrographic-surgery-margins-of-basal-cell-carcinomas-100606952","NCT07182240","Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.\n* Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.\n* The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.\n\nExclusion Criteria:\n\n* Known or reported allergy to mineral oil, the optical agent used during imaging.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* . Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.\n* Unwilling or unable to follow protocol requirements",{"count":122,"type":22},60,[58],"To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).",[26],"2026-05-28",{"date":128,"type":38},"2026-06-01",{"date":130,"type":38},"2025-12-22",{"date":132,"type":22},"2027-06-22",{"name":134,"class":79},"Roswell Park Cancer Institute",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":56,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":46},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":143,"type":22},27,[145],"PHASE2","This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[148,26,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,101,165,166,167,168,169,170,171,172,62,173],"Amyloidosis","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":176,"type":38},"2026-05-18",{"date":178,"type":38},"2025-12-18",{"date":180,"type":22},"2026-12-18",{"name":182,"class":79},"Mayo Clinic",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":191,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":56,"phases":194,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":46},"100455567","phase-3-basal-cell-carcinoma-chemoprevention-trial-100455567","NCT05212246","Basal Cell Carcinoma Chemoprevention Trial","CSP #2019 - Basal Cell Carcinoma Chemoprevention Trial (B3C)","B3C","Inclusion Criteria:\n\n* Veteran age 18 years or older\n* 2 (or more) qualifying BCC lesions in the prior 5 years, with at least one located on the face, neck, ears, or scalp. \"Qualifying lesions are those that meet the two inclusion criterion bullet points below, and none of the exclusion criteria listed in \"B\".\n* Qualifying lesions not in a field of prior radiation therapy.\n* Qualifying lesions not a recurrence after treatment, but the original lesion can qualify whether it recurred or not.\n\nExclusion Criteria:\n\n* AK or KC field therapy on the face (5-FU cream, IMQ, diclofenac gel, chemical peel, or photodynamic therapy) for BCC treatment on the face in the last 2 months because it can cause inflammation that may interfere with the IMQ treatment. After 2 months, these patients can be included.\n* IMQ therapy on the face in the past year, although such therapy in the more distant past is not an exclusion.\n* Suspicious skin lesions suggestive of any type of skin cancer present on the face at the initial exam conducted for the study must be removed and have another skin exam to confirm the facial skin cancer is cleared for 1 month prior to randomization so that the investigators can be confident that skin cancer lesions that arise during the trial are new.\n* Currently receiving or received in the past two months: immune checkpoint inhibitor, hedgehog pathway inhibitor, or oral capecitabine.\n* History of cutaneous T-cell lymphoma within the past year, but low-grade prostate cancer, patch stage CTCL, breast cancer, and history of solid hematologic cancer deemed to be in remission will be included.\n* Genetic disorder associated with very high basal cell skin cancer risk (i.e., basal cell nevus syndrome, xeroderma pigmentosum) because prevention efforts with IMQ may have dramatically different efficacy in these patients compared to the general high-risk population.\n* Solid organ or bone marrow transplant recipient such as renal, hepatic, or cardiac transplant because these patients are at increased risk of KC (much greater risk of SCC than BCC) and the associated immunodeficiency may affect the effectiveness of IMQ\n* Radiation therapy to the face\n* Known allergy to IMQ or cream vehicle\n* Woman currently pregnant or breast feeding\n* Woman of childbearing potential unwilling to use birth control\n* Judged by investigator to have a very high mortality risk within a year due to co-morbid illness\n* Judged by investigator to be unlikely to comply with protocol requirements\n* Judged by investigator not to be competent to provide informed consent\n* Unable to communicate in English\n* Enrolled in another therapeutic interventional trial",true,{"count":193,"type":22},1630,[195],"PHASE3","This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carcinoma (BCC) of the skin on the face at one year and over 3 years after therapy. Participants will apply the IMQ or placebo cream to the face daily at bedtime for 12 weeks. This study will recruit 1630 Veterans at high risk of BCC from 17 VA medical centers.",[26],[26,199,200,201,202,203,204,205,206,207,208,209,210,211],"chemoprevention","imiquimod","facial skin cancer","skin cancer prevention","squamous cell carcinoma","keratinocyte carcinoma","actinic keratosis","quality of life","side effects","treatment compliance","automated text messaging","cost comparison and cost effectiveness","implementation science","NOT_YET_RECRUITING","2026-05-07",{"date":215,"type":38},"2026-05-08",{"date":217,"type":22},"2026-08-03",{"date":219,"type":22},"2032-08-03",{"name":221,"class":222},"VA Office of Research and Development","FED",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100636849","inter-operator-variability-in-the-clinical-staging-and-therapeutic-management-of-basal-cell-carcinoma-100636849","NCT07571031","Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma","BASIX","Inclusion Criteria:\n\n* adult patients ≥ 18 years,\n* histologically confirmed BCC, representing the full EADO spectrum (Stage IIA→ IIIC) and well-quality diagnostic image.\n* Inclusion criteria (physicians)\n\n  * Licensed medical doctors practicing in one of the target specialties: Dermatology, Plastic Surgery, Maxillofacial Surgery, Medical Oncology, or Radiotherapy.\n  * Currently involved in clinical management of BCC\n  * Able to provide informed consent for participation.\n  * Willing and able to complete the online questionnaire within the study timeframe.\n  * Minimum clinical experience: ≥ 1 year after specialty certification\n\nExclusion Criteria for patients:\n\n* not diagnosed BCC cases\n* patients \\\u003C18 years\n\nExclusion Criteria for physicians:\n\n\\- clinical experience \\\u003C1 year after specialty certification",{"count":231,"type":22},20,"Basal cell carcinoma (BCC) is the most frequent skin cancer in humans, primarily located in sun-exposed areas. The incidence of BCC increases with cumulative exposure to ultraviolet (UV) radiation and is particularly high in the elderly population, with a reported peak around 80 years of age. The new EADO classification distinguishes BCCs as 'easy-to-treat' and 'difficult-to-treat', subdivided into stages I-IV, with the aim of guiding therapeutic choices.\n\nHowever, in clinical practice, there is marked variability among specialists in classification and treatment selection, with potential implications for clinical outcomes. This study aims to investigate inter-operator variability in both classification and therapeutic decisions for BCC. Specifically, it analyzes how specialists from different disciplines-dermatologists, oncologists, plastic surgeons, maxillofacial surgeons, and radiation therapists-and with varying clinical experience in BCC management approach the same clinical cases.",[26],"2026-04-30",{"date":236,"type":38},"2026-05-06",{"date":238,"type":22},"2026-05-11",{"date":240,"type":22},"2026-06-20",{"name":242,"class":79},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":46},"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":231,"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.",[31,26,62],{"date":213,"type":38},{"date":255,"type":38},"2025-02-13",{"date":257,"type":22},"2027-02-13",{"name":259,"class":79},"Tiezhi Zhang",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":56,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":46},"100325808","phase-2-nivolumab-alone-or-plus-relatlimab-or-ipilimumab-for-patients-with-locally-advanced-unresectable-or-metastatic-basal-cell-carcinoma-100325808","NCT03521830","Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n\n   1. Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n   2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n2. Type of Participant and Target Disease Characteristics\n\n   1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n   2. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic.\n\n   i) COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone.\n\n   ii) COHORT B: • Patients with advanced BCC who experience disease progression on anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab) will receive anti-PD-1 (nivolumab) + anti-CTLA-4 (ipilimumab).\n\n   iii) COHORT C: • Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (nivolumab) + anti-LAG-3 (relatlimab).\n\n   c. At least one measurable lesion by the RECIST 1.1 Criteria.\n\n   d. Participants with Gorlin syndrome will be permitted to enroll in the study.\n\n   e. Male or female, aged 18 years or older.\n\n   f. Patients may not have received prior T cell modulating agents for BCC (e.g., anti-CTLA-4, anti-PD-L1, anti-LAG-3, anti-KIR, etc.)\n3. Laboratory Testing Requirements\n\n   Screening laboratory values obtained within -28 +\u002F- 3 days of first dose must meet the following criteria:\n   1. White Blood Cells greater than or equal to 2000\u002FμL\n   2. Neutrophils greater than or equal to 1500\u002FμL\n   3. Platelets greater than or equal to 100 x 10³\u002FμL\n   4. Hemoglobin greater than or equal to 9.0 g\u002FdL\n   5. Serum creatinine less than or equal to 1.5 x Upper Limit of Normal (ULN)or creatinine clearance (CrCl) greater than or equal to 40 mL\u002Fminute (using Cockcroft\u002FGault formula)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN, except in patients with liver metastases whose values may be less than or equal to 5 x ULN\n   7. Total Bilirubin less than or equal to 1.5 x ULN (except subjects with Gilbert Syndrome who may have total bilirubin less than or equal to 3.0 mg\u002FdL)\n4. Reproductive Status\n\n   1. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the initial administration of study drug, then every 4 weeks +\u002F- 1 week thereafter for the duration of treatment with study drug(s).\n   2. Women must not be breastfeeding.\n   3. WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion.\n   4. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus approximately 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion.\n   5. Azoospermic males and those who are continuously not heterosexually active are exempt from contraceptive requirements.\n   6. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, however they must still undergo pregnancy testing as described in this section.\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. Pregnant or nursing women\n   2. Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.\n   3. Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.\n   4. Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).\n   5. Viral hepatitis.\n\n   i. Participants with active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\] or hepatitis C virus (HCV) (positive HCV RNA) are excluded.\n\n   ii. Patients with past Hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and the absence of HBsAg) are not ineligible, but HBV DNA quantification must be performed and results discussed with the P.I.\n\n   iii. HBV carriers or those participants requiring antiviral therapy are not eligible to participate.\n\n   iv. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA after discussion with the study P.I.\n\n   f. Participants with a prior malignancy active within the previous 2 years may be permitted to enroll only after discussion with the study P.I. Examples might include locally curable cancers that have been apparently cured, such as squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n\n   g. Organ transplant recipients with a functioning allograft will be excluded from this study.\n\n   h. For Cohorts B and C, patients may be excluded from the study if they previously experienced a toxicity to immunotherapy that, in the opinion of the investigator, would make it unsafe to restart therapy. Examples may include a Grade 3 or greater immune mediated adverse event that was considered related to previous immunotherapy and required immunosuppressive therapy, or an immune mediated adverse event that was considered related to previous immunotherapy and is still \\> grade 1 despite administration of immunosuppressive therapy. Exceptions may include Grade 3 ophthalmologic immune-mediated events that improved to Grade 1 within 2 weeks after topical therapy only, or Grade 3 endocrine immune-mediated events that did not result in symptoms lasting \\>6 weeks and are not requiring \\>7.5mg prednisone or equivalent per day.\n\n   i) For Cohort C, Troponin T (TnT) or I (TnI) \\> 2 × institutional ULN. Participants with TnT or TnI levels between \\> 1 to 2 × ULN will be permitted if a repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between \\>1 to 2 × ULN within 24 hours, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation. When repeat levels within 24 hours are not available, a repeat test will be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2 × ULN, the participant may undergo a cardiac consultation and be considered for treatment, following cardiologist recommendation.\n2. Allergies and Adverse Drug Reaction\n\n   1. History of severe allergy or hypersensitivity to study drug components.\n   2. Patients with a history of a severe toxicity to an immune checkpoint blocking drug may be permitted to enroll only after discussion with the study P.I.\n3. Other Exclusion Criteria\n\n   1. Prisoners or participants who are incarcerated may be permitted to enroll only after discussion with the study P.I.\n   2. Participants who are detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.",{"count":267,"type":22},57,[145],"This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.",[26],"2026-04-27",{"date":273,"type":38},"2026-04-29",{"date":275,"type":38},"2018-11-27",{"date":277,"type":22},"2032-07",{"name":279,"class":79},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":56,"phases":289,"briefSummary":290,"conditions":291,"keywords":292,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100630075","bcc-one-stop-study-100630075","NCT07482956","BCC-One-Stop-Study","Multicentre, Interventional Prospective Study to Evaluate the Efficiency of Pre- and Postoperative Margin Determination of Basal Cell Carcinomas Using Optical Coherence Tomography and Line-field Confocal Optical Coherence Tomography During Micrographically Controlled Surgery","Inclusion Criteria:\n\n* Adults (≥18 years) with basal cell carcinoma (BCC) scheduled for Mohs micrographic surgery (MMS),\n* Diagnosis confirmed by dermoscopy and histopathology or optical coherence tomography (OCT),\n* No limitation regarding tumor size or BCC subgroups.\n\nExclusion Criteria:\n\n* Poor LC-OCT image quality,\n* Incomplete adherence to the study protocol,\n* Previous treatment of the BCC,\n* Anatomical sites that are difficult to access with LC-OCT (e.g., inner ear, medial canthus of the eye).",{"count":288,"type":22},290,[58],"Basal cell carcinoma (BCC) is the most common malignant skin tumour. The standard treatment is micrographically controlled surgery (MMS), which achieves high cure rates but requires considerable time and personnel. A key problem is the inadequate preoperative determination of tumour margins, which often leads to multiple cycles of excision.\n\nThe aim of this multicentre, prospective, randomised controlled intervention study is to evaluate line-field confocal optical coherence tomography (LC-OCT) for preoperative margin determination in BCC within the framework of MMS.\n\nResearch question:\n\nCan preoperative LC-OCT-assisted margin marking increase the efficiency of MMS by reducing the number of excision cycles required without compromising oncological safety?\n\nMethodology:\n\nApproximately 290 patients with histologically confirmed BCC will be enrolled at five German centres and randomly assigned to either standard MMS or MMS with upstream LC-OCT margin determination. In the intervention group, the excision margin will be specifically extended if a tumour is detected in the LC-OCT.\n\nPrimary endpoint:\n\nNumber of MMS cycles required to achieve R0 resection.\n\nSecondary endpoints:\n\nTotal duration of surgery, size of surgical defect, cosmetic outcome (POSAS), patient satisfaction and stress, sensitivity and specificity of LC-OCT compared to histopathology.\n\nSignificance:\n\nThe study addresses the clinical conflict of objectives between complete tumour removal and maximum tissue preservation. Successful implementation could optimise MMS through modern imaging, conserve surgical resources and improve patient care in the long term.",[26],[293,294,295,296,297,298,299,300,301,302],"basal cell carcinoma","line-field confocal optical coherence tomography","BCC","LC-OCT","Mohs micrographic surgery","MMS","margin mapping","margin assessment","skin cancer","one stop shop","2026-03-16",{"date":305,"type":38},"2026-03-19",{"date":307,"type":22},"2026-04-01",{"date":309,"type":22},"2027-12-31",{"name":311,"class":79},"University Hospital Augsburg",5,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":56,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100564077","phase-2-neoadjuvant-nivolumab--relatlimab-opdualag-versus-nivolumab-for-resectable-high-risk-basal-cell-carcinoma-100564077","NCT06624475","Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma","Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma","NEON","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document.\n2. Participants must have histologically or cytologically confirmed basal cell carcinoma.\n3. Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk\u002Fextremities.\n4. Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or anticipated to require skin grafting or free flap reconstruction per investigator assessment.\n5. Participants must have treatment naive BCC.\n6. Aged 18 years or older.\n7. Eastern Cooperative Oncology Group Performance Status 0 or 1\n8. Demonstrates adequate organ function as defined below:\n\n   Adequate bone marrow function\n   1. Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n   2. Platelets ≥ 100,000\u002Fmicroliter\n\n      Adequate hepatic function\n   3. Total bilirubin \\>1.5 x institutional upper limit of normal (except participants with Glibert Syndrome who must have a total bilirubin level of \\\u003C3.0xULN)\n   4. Aspartate aminotransferase (AST or SGOT) ≤ 3 x institutional upper limit of normal\n   5. Alanine transaminase (ALT or SGPT) ≤ 3 x institutional upper limit of normal\n\n      Adequate renal function\n   6. Creatinine clearance Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin (using the Cockcroft Gault formula)\n9. Human immunodeficiency virus (HIV) infected individuals on effective anti retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must not have had an AIDS defining opportunistic infection within the last year or a current CD4 count \\\u003C 350 cells\u002Fmicroliter.\n10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n11. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n12. Concurrent malignancy (present during screening) requiring treatment or history o f prior malignancy active within 2 years prior to randomization (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non invasive or in situ cancers that have undergone definitive treatment at any time are also eligible.\n13. The effects of Opdualag on the on the developing human fetus are unknown. Therefore, the following criteria apply to participants in each study arm:\n\nCohort 1 Opdualag:\n\nA woman of child bearing potential (WOCBP) is eligible to enroll if using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, during the intervention period and for the duration of treatment with Opdualag plus 5 half lives of study treatment for a total of 5 months post treatment completion and agrees not to donate eggs (ova, oocytes) for the purpose of re production for the same time period.\n\nCohort 2 nivolumab:\n\ni. Women who are not of childbearing potential are exempt from contraceptive requirements.\n\nii. Women participants must have documented proof that they are not of childbearing potential.\n\niii. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24 hour window. iv. Additional requirements for pregnancy testing during and after study intervention are located in the Schedule of Assessments.\n\nv. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. vi. WOCBP must agree to follow instructions for method(s) of contraception and as described below and included in the Informed Consent Form.\n\nvii. WOCBP are permitted to use hormonal contraception methods viii. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n1. Is not a WOCBP. OR\n2. Is a WOCB P and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, during the intervention period and for at least 5 months and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period.\n\nExclusion Criteria:\n\n1. Is currently receiving any other investigational agents.\n2. Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.\n3. Hypersensitivity to Opdualag, nivolumab, or any of their excipients.\n4. Presence of untreated (symptomatic) central nervous system metastases.\n5. Presence of leptomeningeal metastatic disease.\n6. Treatment with any live \u002F attenuated vaccine within 30 days of first study treatment.\n7. Radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤1 or at baseline) from radiation related toxicities prior to first study treatment.\n8. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n9. Participants with an active, known, or suspected autoimmune disease. Note: Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n10. Prior allogeneic tissue\u002Fsolid organ transplant.\n11. Severe uncontrolled cardiac disease within 6 months of screening, including but not limited to poorly controlled hypertension , unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or clinically significant uncontrolled cardiac arrhythmias.\n12. Any prior history of myocarditis and\u002For current diagnosis of myocarditis, regardless of etiology.\n13. Troponin T (TnT) or I (TnI) \\> 2 x institutional upper limit of normal (ULN).\n\n    1. Participants with TnT or TnI levels between \\> 1× to 2× ULN will be permitted if repeat levels within 24 hours are ≤ 1× ULN. I f TnT or TnI levels are between \\> 1× to 2× ULN within 24 hours, the participant must be evaluated by a cardiologist. When repeat levels within 24 hours are not available, a repeat test should be conducted as soon as possible. If TnT or TnI repeat levels beyond 24 hours are \\\u003C 2× ULN, the participant must be evaluated by a cardiologist.\n    2. After cardiologist evaluation, the participant may be considered for randomization if the Investigator assesses a favorable benefit\u002Frisk.\n14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient an inappropriate candidate for the study.\n15. Pregnant women are excluded from this study because Opdualag are immune checkpoint inhibitors with the potential for teratogenic o r abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Opdualag, breastfeeding should be discontinued if the mother is treated prior to initiating study treatment.",{"count":322,"type":22},30,[145],"This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)",[26],"2026-02-02",{"date":328,"type":38},"2026-02-05",{"date":330,"type":38},"2025-08-21",{"date":332,"type":22},"2028-05",{"name":334,"class":79},"University of California, San Diego",3,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":56,"phases":345,"briefSummary":347,"conditions":348,"keywords":364,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":344,"type":22},56,[346],"PHASE1","Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[349,350,26,295,351,101,165,352,353,354,355,356,357,358,359,360,361,362,363],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","BCC - Basal Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Head and Neck Squamous Cell Carcinoma","HNSCC","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Refractory Cancer","Solid Tumor",[349,350,26,295,101,165,352,353,354,355,356,357,358,359,360,361,362,365,366,367,363],"MQ710","Memorial Sloan Kettering Cancer Center","22-278","2025-12-02",{"date":370,"type":38},"2025-12-03",{"date":372,"type":38},"2023-05-04",{"date":374,"type":22},"2028-05-04",{"name":366,"class":79},7,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":56,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":46},"100482407","phase-2-radiotherapy-by-sonic-hedgehog-pathway-inhibitors-in-basal-cell-carcinoma-100482407","NCT05561634","Radiotherapy by Sonic Hedgehog Pathway Inhibitors in Basal Cell Carcinoma","Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study","RADIOSONIC","Inclusion Criteria:\n\n* Patient over 18 years\n* Locally advanced non-recurrent BCC in complete response after first course of SHHi\n* Complete response has to be confirmed histologically\n* Available photography or CT scan before SHHi treatment allowing delineation of the initial tumor\n\nExclusion Criteria:\n\n* Patients with distant metastasis\n* Patients with Gorlin's syndrome\n* Prior radiotherapy to the region of the studied cancer that would result in overlap of radiation therapy fields\n* Pregnant women\n* Life expectancy less than 1 year\n* Inability to receive informed consent\n* Inability to participate in the entire study\n* Lack of social security coverage\n* Refusal to sign consent",{"count":386,"type":22},82,[145],"Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a \"consolidation radiotherapy\" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.",[26,390],"Radiotherapy; Complications",[392,393,394],"Locally advanced basal cell carcinoma","Sonic Hedgehog inhibitors","Consideration radiotherapy","2025-09-24",{"date":397,"type":38},"2025-09-30",{"date":399,"type":38},"2023-06-20",{"date":401,"type":22},"2029-06-20",{"name":403,"class":79},"University Hospital, Lille",{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":335},"100557295","personalised-immunotherapy-platform-100557295","NCT06536257","Personalised Immunotherapy Platform","Personalised Immunotherapy Platform (PIP) - Implementation of a Predictive Model of Response to Immunotherapies in Melanoma","PIP-PREDICT","MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue, blood and stool and collection of standard clinical data.\n2. Histologically confirmed resected stage II (at high risk of recurrence of disease), III or stage IV melanoma (including cutaneous, mucosal, acral, subungual, uveal or unknown primary melanoma) and unresectable Stage III or IV melanoma\n3. Eligible to receive immunotherapy\n4. Availability of a melanoma tissue sample which was obtained at surgery and where no systemic treatments (e.g. adjuvant treatment) were administered between sample procurement and proposed PIP testing\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease\n6. RECIST version 1.1 measurable disease.\n7. Tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with BRAF (B-Raf proto-oncogene) \u002F MEK (mitogen-activated protein kinase) inhibitors are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field.\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required\n\nNON-MELANOMA:\n\nInclusion Criteria:\n\n1. Written informed consent to participation for the use of tumour tissue and collection of standard clinical data\n2. Histologically confirmed cancer and eligibility to receive immunotherapy treatment.\n3. Availability of a tissue sample where no systemic treatments were administered between sample procurement and proposed PIP testing\n4. If treatment has been administered since the last tissue sample was obtained, a new biopsy should be planned for routine testing or clinical trial screening, where a portion of the sample can be used for the predictive assay. No new biopsies are required for the sole purpose of this study.\n5. Patients who have received adjuvant or neoadjuvant systemic therapy in the past are eligible if they have had recurrence after neoadjuvant or adjuvant therapy has been completed and the biopsy represents this relapsed disease.\n6. Have clinically detectable disease defined as one of more of the following:\n\n   * RECIST measurable. Lesions situated in a previously irradiated area are considered measurable if RECIST-defined disease progression since radiotherapy has been demonstrated in such lesions, OR,\n   * Positron Emission Tomography (PET) avid, OR,\n   * Clinically evident disease: photographically, detectable on CT or palpable, OR\n   * Clinical status measured by observable and diagnosable signs or symptoms.\n7. The tissue sample must be representative of the whole tumour and therefore excision biopsies are preferred over core biopsies.\n8. A life expectancy over 6 months.\n9. Prior treatment with targeted therapies are acceptable, providing the other eligibility criteria are met.\n10. If a patient has had prior radiotherapy for melanoma, the biopsy to be used for the biomarker test must be from an area that was not within the radiotherapy field\n\nExclusion Criteria:\n\n1\\. Patients will be excluded if they have had a positive test result for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection. If receiving treatment and from HCV for at least one year, patients are allowed to participate. No new testing is required for the sole purpose of this pilot phase. Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). No new testing is required",{"count":413,"type":22},1000,"This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.",[101,349,26,165,363],[417,418,419,420,421,422,423,424,425,426,427],"Biomarker","Predictive","Immunotherapy","Multi-omic","Tumour mutation burden","Gene expression","Tissue imaging","Machine learning","Multiplex immunofluorescence","Immune checkpoint inhibitors","Quantitative pathology","2025-09-12",{"date":430,"type":38},"2025-09-18",{"date":432,"type":38},"2021-06-08",{"date":434,"type":22},"2037-06-01",{"name":436,"class":79},"Melanoma Institute Australia",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":453,"locationsCount":46},"100562207","intraoperative-confocal-laser-scanning-microscopy-with-use-of-ai-for-optimized-surgical-excision-of-basal-cell-carcinoma-100562207","NCT06600165","Intraoperative Confocal Laser Scanning Microscopy With Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma","Intraoperative Confocal Laser Scanning Microscopy and Artificial Intelligence for Optimized Surgical Excision of Basal Cell Carcinoma","Inclusion Criteria:\n\n* Patients with Basal Cell Carcinoma\n\nExclusion Criteria:\n\n* Patient unable to consent",{"count":413,"type":22},"The aim is to use AI to assist surgeons in analyzing CLSM tissue slide images obtained during BCC surgeries with the aim to integrate it in real time. We plan to use AI to analyze CLSM images of BCCs and distinguish between tumor tissue, inflammatory tissue, and non-tumor\u002Fnon-inflammatory tissue. This approach would provide surgeons with real-time feedback and automated image analysis, leading to a more targeted and efficient approach to tissue analysis. By improving the accuracy and speed of tissue analysis, our proposal could ultimately improve operative patient outcomes and benefit healthcare professionals.",[26],"2025-09-02",{"date":449,"type":38},"2025-09-09",{"date":451,"type":38},"2025-03-01",{"date":309,"type":22},{"name":454,"class":79},"LMU Klinikum",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":56,"phases":465,"briefSummary":466,"conditions":467,"keywords":499,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":143},"100445919","phase-1-a-beta-only-il-2-immunotherapy-study-100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":464,"type":22},115,[346,145],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[468,469,470,471,472,473,474,475,476,26,477,165,478,349,479,480,154,363,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,31,496,497,498],"Advanced Solid Tumor","Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Gastric Cancer","Cervical Cancer","Bladder Cancer","Squamous Cell Carcinoma of Head and Neck","Pleural Mesothelioma","Esophageal Cancer","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","MSI-H Cancer","DMMR Cancer","Pancreas Adenocarcinoma (MSI-H)","Viral Cancer","Cervical Cancers","Endometrial Cancer",[500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,295,525,526,527,528,529],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","MSI-H","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","immunotherapy","anti-PD-1","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":532,"type":38},"2025-07-09",{"date":534,"type":38},"2021-08-27",{"date":536,"type":22},"2026-12-30",{"name":538,"class":539},"Medicenna Therapeutics, Inc.","INDUSTRY",{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":11,"sex":17,"minAge":548,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":56,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":572},"100545603","skin-cancer-and-hyperthermia-and-radiotherapy-100545603","NCT06384053","Skin Cancer and Hyperthermia and Radiotherapy","Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial","SAHARA","Inclusion Criteria:\n\n* Personally signed and dated written informed consent\n* Histologically confirmed invasive non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of any differentiation\n* ≥ T2 (TNM Classification 8th Edition)\n* Tumor thickness up to 2cm (Maximum Depth invasion and\u002For exophytic growth, measured on pathology report or imaging)\n* Local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (RT))\n* Age ≥ 65 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy of more than 6 months\n* Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory\n\nExclusion Criteria:\n\n* Other histology than BCC or SCC\n* T1 tumor and\u002For N+ (according to TNM classification 8th edition)\n* Tumors after resection (R1 or R2 as well as adjuvant indication)\n* Tumor invasion into critical areas\n* Several lesions exceeding the capacity of one treatment\u002Fradiation field (multiple lesions within one treatment field are acceptable)\n* Previous (one month) or concurrent Chemo- or Immunotherapy\n* Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)\n* Lesions inside or in proximity (within 3cm) previously irradiated area\n* Medical immunosuppression\n* wIRA-specific exclusion criteria\n\n  * Tattoos in irradiated area\n  * Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)","65 Years",{"count":550,"type":22},100,[58],"The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC).",[26,554,555],"Squamous Cell Carcinoma Skin","Non-melanoma Skin Cancer",[295,557,558,559,560,561,562],"SCC skin","w-IRA hyperthermia","radiotherapy for non-melanoma skin cancer","non-melanoma Skin cancer","w-IRA combined with RT","hyperthermia","2025-06-11",{"date":565,"type":38},"2025-06-15",{"date":567,"type":38},"2025-01-01",{"date":569,"type":22},"2028-07-01",{"name":571,"class":79},"Kantonsspital Winterthur KSW",4,{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":46},"100539899","retrospective-and-prospective-observational-study-in-patients-with-advanced-basal-cell-carcinoma-100539899","NCT06309836","Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma","REGISTRO-BCC","Inclusion Criteria:\n\n1. Male and female patients aged ≥ 18 years\n2. Patients diagnosed with advanced basal cell carcinoma of the skin, i.e. tumours included in at least one of the following categories: locally advanced carcinoma (not radically treatable by surgery and\u002For radiotherapy), carcinoma with lymph node and\u002For distant metastatic localisation\n3. patients who have had at least one access (first visit or follow-up visit) at the dermatology or oncology outpatient clinic of the centres involved\n\n   * Patients diagnosed with advanced BCC who have accessed the centre from 1 January 2016 until the date of activation of the centre will be included in the retrospective cohort;\n   * Patients diagnosed with advanced BCC who have accessed the centre from the date of activation\n4. Signature of informed consent\n\nExclusion Criteria:\n\nPatients incapable of giving informed consent",{"count":581,"type":22},250,"Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma.",[26],"2025-06-09",{"date":586,"type":38},"2025-06-12",{"date":588,"type":38},"2021-06-23",{"date":590,"type":22},"2029-12-31",{"name":592,"class":79},"Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse",{"id":594,"slug":595,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":56,"phases":603,"briefSummary":604,"conditions":605,"keywords":612,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":622},"100445254","phase-3-study-comparing-the-standard-administration-of-io-versus-the-same-io-administered-each-3-months-in-patients-in-response-after-6-months-of-standard-io-100445254","NCT05078047","Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO","Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Locally Advanced or Metastatic Cancer in Response After 6 Months of Standard IO","MOIO","Inclusion Criteria:\n\n1. Patients must have signed a written informed consent form prior to any trial specific procedures.\n2. Patient aged ≥18 years old.\n3. Metastatic disease (or locally advanced disease not suitable for local treatment) of initial tumor histologically confirmed including: lung cancer, renal cell cancer, head and neck cancer, urothelial carcinoma, triple negative breast cancer, Merkel cancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite instability \\[MSI\\], esophageal squamous cell carcinoma, endometrial carcinoma,cervical cancer, gastric\u002Fgastro-oesophageal junction adenocarcinoma, basal cell carcinoma or squamous skin carcinoma.\n4. Patients in partial or complete response after 6 months of standard immunotherapy (whatever the line of therapy) according to the RECIST or PERCIST v1.0 criteria (confirmed by local radiological assessment).\n\n   For metastatic melanoma only patients in partial response. Patients with metastatic or advanced cancer treated by immunotherapy as maintenance therapy can be included without any lesion at IO initiation. In this case, response after 6 months of standard immunotherapy will be evaluated by the non-appearance of a new lesion.\n5. Eligible to maintain the same standard IO treatment.\n6. Patient with Eastern cooperative oncology group (ECOG) performance status ≤1.\n7. Patients with brain metastases are allowed, provided they are stable according to the following definitions: treated with surgery or stereotactic radiosurgery and without evidence of progression prior to randomization and have no evidence of new or enlarging brain metastases.\n8. Patients treated by IO previously combined with chemotherapy are allowed.\n9. Patients with Tyrosine Kinase Inhibitor (TKI)-IO or pemetrexed-IO or bevacizumab-IO are allowed.\n10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for pre-menopausal patients.\n11. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use adequate contraception method for the duration of the study treatment and after completing treatment according to the most recent version of the IO Summary of product characteristics (SmPC).\n12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n13. Patient must be affiliated to a Social Security System.\n\nExclusion Criteria:\n\n1. Metastatic melanoma in complete response.\n2. Metastatic renal cell carcinoma with International Metastatic Renal Cell Carcinoma Database (IMDC) favourable-risk treated TKI\u002FIO combination.\n3. Hematologic malignancies (leukaemia, myeloma, lymphoma…)\n4. Active infection requiring systemic therapy.\n5. Patients enrolled in another therapeutic study within 30 days before the inclusion in and during MOIO study.\n6. Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study.\n7. Person deprived of their liberty or under protective custody or guardianship.",{"count":602,"type":22},646,[195],"Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.",[606,172,607,471,165,160,101,173,608,609,154,476,610,26,611],"Lung Cancer Metastatic","Head and Neck Cancer","Colorectal Carcinoma With Microsatellite Instability","Esophageal Squamous Cell Carcinoma","Gastric\u002FGastro-esophageal Junction\u002FEsophageal Adenocarcinoma","Squamous Skin Carcinoma",[419],"2025-06-04",{"date":615,"type":38},"2025-06-05",{"date":617,"type":38},"2022-03-08",{"date":619,"type":22},"2027-03-07",{"name":621,"class":79},"UNICANCER",40,{"id":624,"slug":625,"hasResults":11,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":630,"targetDuration":632,"studyType":23,"phases":4,"briefSummary":633,"conditions":634,"keywords":644,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":659},"100474888","oral-hedgehog-inhibitors-in-the-treatment-of-basal-cell-carcinoma-in-the-netherlands-a-prospective-registration-study-100474888","NCT05463757","Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study","Registration of Oral Hedgehog Inhibitors Vismodegib and Sonidegib in the Treatment of Advanced and Multiple Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study.","Inclusion Criteria:\n\n* Men and women\n* All ages\n* Diagnosed with locally advanced basal cell carcinoma (laBCC), metastatic basal cell carcinoma (mBCC), multiple basal cell carcinomas or Gorlin syndrome\n* Use of oral hedgehog inhibitor vismodegib or sonidegib\n\nExclusion Criteria:\n\n* None",{"count":631,"type":22},80,"3 Years","Background: Oral hedgehog inhibitors vismodegib and sonidegib have been used for the treatment of locally advanced (laBCC), metastatic basal cell carcinoma (mBCC) and in basal cell nevus syndrome (BCNS) patients. In the Netherlands, targeted therapy with vismodegib and sonidegib has been available since 2013 and 2021, respectively. No direct comparative studies have been performed between the two oral hedgehog inhibitors (HHI) vismodegib and sonidegib yet . In addition, data for sonidegib are not yet available.\n\nObjective: The aim of this study is 1) to evaluate the effectiveness of oral HHIs in the treatment of laBCC, mBCC and BCNS patients and 2) to compare the oral HHIs vismodegib and sonidegib.\n\nStudy design: prospective registration study that includes all patients, regardless of age and gender, with histologically proven basal cell carcinoma receiving treatment with either vismodegib or sonidegib in the Netherlands. Patient, tumor and treatment information was gathered from patient records.\n\nMain study parameters\u002Fendpoints: The primary outcome for measuring efficacy\u002Ftumor response was median progression free survival (PFS) where the decrease, stagnation or increase in tumor size is measured by maximum diameter. Secondary outcomes are frequency, severity and reversibility of treatment-emergent adverse events and disease-specific quality of life expressed as mean scores on the EORTC-QLQ-C30 and aBCCdex questionnaires.",[26,635,636,637,638,639,640,641,31,642,643],"Locally Advanced Basal Cell Carcinoma","Metastatic Basal Cell Carcinoma","Gorlin Syndrome","Basal Cell Nevus Syndrome","Carcinoma, Basal Cell","Carcinoma","Basal Cell Tumor","Neoplasm of Skin","Neoplasms, Basal Cell",[645,646,647,648,649],"Oral hedgehog inhibitors","Vismodegib","Sonidegib","Erivedge","Odomzo","2025-04-02",{"date":652,"type":38},"2025-04-04",{"date":654,"type":38},"2021-11-01",{"date":656,"type":22},"2026-12",{"name":658,"class":79},"Maastricht University Medical Center",8,{"id":661,"slug":662,"hasResults":11,"nctId":663,"briefTitle":664,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":56,"phases":668,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":46},"100552439","investigation-of-standard-excision-surgical-margins-using-two-photon-fluorescence-microscopy-100552439","NCT06473103","Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy","Inclusion Criteria:\n\n* Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site\n* Able to read and understand consent form\n\nExclusion Criteria:\n\n* None",{"count":667,"type":22},52,[58],"The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.",[26],"2025-03-14",{"date":673,"type":38},"2025-03-17",{"date":675,"type":38},"2024-10-29",{"date":677,"type":22},"2026-04",{"name":679,"class":79},"University of Rochester",{"id":681,"slug":682,"hasResults":11,"nctId":683,"briefTitle":684,"officialTitle":684,"acronym":4,"eligibilityCriteria":685,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":686,"targetDuration":688,"studyType":23,"phases":4,"briefSummary":689,"conditions":690,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":46},"100496195","outcome-research-of-a-european-registry-platform-on-real-world-treatment-data-of-patients-with-advanced-nmsc-100496195","NCT05741073","Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC","Inclusion Criteria:\n\n1. Patients aged ≥18 years at index date\n2. Patients documented in the European NMSC-registry fulfilling EMR quality standard\n3. Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery\u002Fradiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery\u002Fradiation in routine clinical practice (Cohort 3)\n\nExclusion Criteria:\n\n1\\. Patients receiving treatment within a clinical trial.",{"count":687,"type":22},1300,"5 Years","This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC\u002FBCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.",[26,349],"2025-03-10",{"date":693,"type":38},"2025-03-12",{"date":695,"type":38},"2023-06-30",{"date":697,"type":22},"2027-12",{"name":699,"class":539},"EuMelaReg gGmbH",{"id":701,"slug":702,"hasResults":11,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":4,"eligibilityCriteria":706,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":707,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":709,"conditions":710,"keywords":712,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":4},"100537122","d-oct-for-detection-and-subtyping-of-bcc-a-diagnostic-cohort-study-100537122","NCT06273722","D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study","Dynamic Optical Coherence Tomography for Detection and Subtyping of Basal Cell","Inclusion Criteria:\n\n* 18+ years\n* Lesions suspect for non-melanoma skin cancer or premalignancy\n* Patient underwent D-OCT scan and biopsy conform regular care\n\nExclusion Criteria:\n\n* Patient unable to sign informed consent.",{"count":708,"type":22},424,"The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.\n\nDescriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.",[26,711],"Optical Coherence Tomography",[713,714,715,716],"Basal cell carcinoma","Optical coherence tomography","Imaging","Non-melanoma skin cancer","2024-10-23",{"date":719,"type":38},"2024-10-26",{"date":721,"type":22},"2024-11-01",{"date":723,"type":22},"2025-08-01",{"name":658,"class":79},{"id":726,"slug":727,"hasResults":11,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":4,"eligibilityCriteria":731,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":732,"targetDuration":4,"studyType":56,"phases":733,"briefSummary":734,"conditions":735,"keywords":736,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":741,"completionDateStruct":743,"leadSponsor":745,"locationsCount":747},"100542529","phase-2-to-assess-the-safety-and-efficacy-of-sp-002-with-vismodegib-for-the-treatment-of-locally-advanced-basal-cell-carcinoma-100542529","NCT06344052","To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma","A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma","Inclusion Criteria:\n\n1. Subject has provided written informed consent prior to initiation of study-specified procedures.\n2. Subject is 18 years of age or older.\n3. Eastern Cooperative Oncology Group performance status 0, 1 or 2.\n4. Subject has a single lesion that is histologically confirmed as BCC. The externally visible component of the lesions should be at least 1 cm in one dimension to facilitate accurate and reproducible measurement, to 5 cm at longest diameter, that in the opinion of the investigator:\n\n   A. is considered not a good candidate for surgery or has recurred after definitive surgical treatment and curative surgical resection is unlikely. OR\n\n   B. subject has a medical contraindication to surgery where acceptable medical contraindications to surgery include:\n   * Anticipated substantial morbidity and\u002For deformity from surgery (e.g., removal of all or part of a vital facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation).\n   * Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing).\n   * Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the subject.\n\n   A copy of the surgical consultation note must be provided. laBCC with prior history of or ongoing HPPI treatment are eligible under the following conditions:\n   * Achieved objective response with disease progression \\>3 months after treatment discontinuation.\n   * Achieve best response of PR with persistent disease that continues to meet study inclusion criteria and has been off treatment for at least 3 months.\n\n   Note: where the subject has \\>1 lesion, one lesion may be selected for treatment at the discretion of the investigator.\n5. Radiotherapy is contraindicated or inappropriate in the opinion of the investigator, for example, hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or anticipated significant morbidity, loss of function, or unacceptable cosmetic outcomes. Patients with Basal Cell Nevus Syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or listed above.\n6. Subject is able and willing to comply with all study requirements including biopsies at baseline and during the study. Biopsy 3-4 mm preferred, biopsies must be \\\u003C25% of the area the tumor. Screening biopsies performed 1-12 weeks before Day 1.\n7. Subject has adequate hematopoietic capacity, as defined by the following:\n\n   * Neutrophil count \\>1,500\u002Fmm3\n   * Hemoglobin \\>9 g\u002FdL\n   * Platelet count \\>100,000\u002F mm3\n   * Prothrombin international normalized ratio \\\u003C1.5\n8. Subject has adequate hepatic function, as defined by the following:\n\n   * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) or within 3 × the ULN for patients with Gilbert disease\n   * Aspartate aminotransferase, alanine aminotransferase or alkaline phosphate \\\u003C2 × the ULN\n9. Adequate renal function, as defined by the following:\n\n   * Creatinine \\\u003C1.5 x ULN\n10. For female subjects of childbearing potential\\*, agreement to use two acceptable methods of contraception (including one barrier method), during the study and for at least (per United States Prescribing Information \\[USPI\\]) 24 months after discontinuation of vismodegib.\n\n    For male subjects with female partners of childbearing potential\\*, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for at least (per USPI) 24 months after discontinuation of vismodegib.\n11. Subjects agree not to donate blood or blood products during the study and for at least (per USPI) 24 months after discontinuation of vismodegib; male subjects agree not to donate sperm during the study and for at least 2 months after discontinuation of vismodegib.\n\n    * Childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. In addition, females under the age of 55 years must have a documented serum follicle stimulating hormone level \\>40 mIU\u002FmL to confirm menopause.\n\nExclusion Criteria:\n\n1. laBCC that has progressed on systemic HHPI therapy as defined below:\n\n   * Best response of progressive disease (primary progression).\n   * Objective response followed by disease progression while on HHPI treatment.\n   * laBCC with a best response of stable disease on systemic HHPI treatment.\n2. laBCC that has recurred in the same location after two or more surgical procedures, or that has recurred following radiation therapy.\n3. laBCC that has bone involvement (radiologically confirmed if clinically suspected).\n4. laBCC with invasion of underlying soft tissue that is not accessible by standard syringe\u002Fneedle.\n5. Patients with evidence of metastatic BCC.\n6. Female subjects who are lactating or pregnant.\n7. Life expectancy of \\\u003C12 weeks.\n8. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, or radiation therapy).\n9. Recent (within 4 weeks of Day 1), current, or planned participation in an experimental drug study.\n10. History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated basal and squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.\n11. Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics.\n12. History of other stable disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the subject at high risk from treatment complications.",{"count":631,"type":22},[145],"The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.\n\nResearchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.\n\n* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.\n* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.\n* Arm 3 participants will receive daily hedgehog pathway inhibitor only.",[26],[737],"locally advanced","2024-09-18",{"date":740,"type":38},"2024-09-20",{"date":742,"type":38},"2024-04-09",{"date":744,"type":22},"2029-03-30",{"name":746,"class":539},"Stamford Pharmaceuticals, Inc.",10]