CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mucosal Melanoma of the Head and Neck, Oral Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Study Design This is a multicenter, bidirectional (retrospective + prospective) observational cohort study designed to establish a high-quality evidence platform for oral mucosal melanoma (OMM), a rare malignancy with high aggressiveness and poor prognosis. The study is conducted at four tertiary hospitals in China: Shanghai Ninth People's Hospital (lead center), Air Force Medical University Stomatological Hospital, Xiangya Hospital of Central South University, and Sun Yat-sen Memorial Hospital of Sun Yat-sen University.
Study Population The cohort will include a total of 1,100 Chinese patients with histopathologically confirmed primary OMM.
Retrospective cohort (n=800): Patients diagnosed between January 2015 and June 2025, with complete medical records, pathological slides, and available follow-up data.
Prospective cohort (n=300): Consecutive newly diagnosed patients enrolled from July 2025 to December 2028, after providing written informed consent.
Primary outcome measures
- overall survival [Time frame: 24months]
Eligibility criteria
Inclusion criteria
- Histopathologically confirmed primary oral mucosal melanoma (WHO criteria);
Primary site: oral mucosa (palate, gingiva, sublingual, buccal, hard palate, floor of mouth);
Receiving or planning standard treatment (surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy);
Age ≥18 years, any sex;
Complete clinical data with pathology, imaging, and records (retrospective) OR willingness for long-term follow-up (prospective);
Signed informed consent (prospective) or data meeting ethical waiver (retrospective).
Exclusion criteria
- Primary melanoma originating from skin, eye, esophagus, or other non-oral mucosal sites;
Secondary/metastatic oral mucosal melanoma (primary not in oral cavity);
Unavailable key clinical information (surgical records, pathology, imaging);
Prior or concurrent other malignancy interfering with prognosis;
Severe mental/cognitive disorders or poor compliance;
Severe comorbidities (heart failure, liver/renal failure) affecting treatment or survival analysis;
Patient refusal or withdrawal of informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07662694 · SH9H-2026-T244-1 · 2025DLC02