[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mucosal-melanoma-of-the-head-and-neck\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mucosal-melanoma-of-the-head-and-neck":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644407","classify-omm-multicenter-rare-disease-cohort-for-t-stage-reclassification-and-molecular-subtyping-based-precision-therapy-in-oral-mucosal-melanoma-100644407",false,"NCT07662694","CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma","CLASSIFY-OMM","Inclusion Criteria:\n\n* Histopathologically confirmed primary oral mucosal melanoma (WHO criteria);\n\nPrimary site: oral mucosa (palate, gingiva, sublingual, buccal, hard palate, floor of mouth);\n\nReceiving or planning standard treatment (surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy);\n\nAge ≥18 years, any sex;\n\nComplete clinical data with pathology, imaging, and records (retrospective) OR willingness for long-term follow-up (prospective);\n\nSigned informed consent (prospective) or data meeting ethical waiver (retrospective).\n\nExclusion Criteria:\n\n* Primary melanoma originating from skin, eye, esophagus, or other non-oral mucosal sites;\n\nSecondary\u002Fmetastatic oral mucosal melanoma (primary not in oral cavity);\n\nUnavailable key clinical information (surgical records, pathology, imaging);\n\nPrior or concurrent other malignancy interfering with prognosis;\n\nSevere mental\u002Fcognitive disorders or poor compliance;\n\nSevere comorbidities (heart failure, liver\u002Frenal failure) affecting treatment or survival analysis;\n\nPatient refusal or withdrawal of informed consent.","ALL","18 Years",{"count":19,"type":20},1100,"ESTIMATED","OBSERVATIONAL","This bidirectional cohort study (retrospective + prospective) focuses on three key challenges in oral mucosal melanoma (OMM): clinical staging based on depth of invasion (DOI), molecular subtyping, and precision therapy. By integrating DOI-driven T-stage reclassification, genomic profiling, and longitudinal follow-up, we aim to build a population-specific, high-quality evidence resource to support refined staging, CDK4-targeted treatment, and prognostic modeling for Chinese OMM patients.",[24,25],"Mucosal Melanoma of the Head and Neck","Oral Melanoma",[27],"Mucosal Melanoma","NOT_YET_RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":20},"2026-07-01",{"date":36,"type":20},"2029-12-30",{"name":38,"class":39},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100386975","phase-2-pembrolizumab-and-hypofractionated-radiation-therapy-for-the-treatment-of-mucosal-melanoma-100386975","NCT04318717","Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma","Adjuvant Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed mucosal melanoma that has undergone surgical resection. Patient must not have received prior radiation therapy within the area of interest.\n* At least 16 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%)\n* Normal bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1,200\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of pembrolizumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and 6 months after last dose of pembrolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after last dose of pembrolizumab.\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.\n* Received radiation therapy within the area of interest.\n* Currently receiving any other investigational agents.\n* Metastatic disease.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of up to 10 mg\u002Fday of prednisone or equivalent is approved and does not exclude the patient from the trial.\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, \\> 10 mg of prednisone per day, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The use of up to 10 mg\u002Fday of prednisone or equivalent is approved and does not exclude the patient from the trial.\n* Has a history of (non-infectious) pneumonitis\u002FInterstitial lung disease that required maintenance steroids (\\>10 mg of prednisone) or current pneumonitis\u002Finterstitial lung disease.\n* Has received a live vaccine or live-attenuated vaccination within 30 days of planned treatment start. Administration of killed vaccines is allowed.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.","16 Years",{"count":50,"type":20},20,"INTERVENTIONAL",[53],"PHASE2","This is an open-label, single center, one cohort, non-randomized, phase II study. The aim is to evaluate the efficacy and safety of the combination of hypofractionated radiotherapy (HRT) and pembrolizumab on local tumor control in mucosal melanoma patients. Treatment effect will be compared with historical radiation therapy-alone control data.",[24],"RECRUITING","2026-05-22",{"date":59,"type":32},"2026-05-27",{"date":61,"type":32},"2020-05-29",{"date":63,"type":20},"2032-07-31",{"name":65,"class":39},"Washington University School of Medicine"]