CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
Starting soon
Conditions studied: Mucosal Melanoma of the Head and Neck, Oral Melanoma
In brief
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.
Key facts
- Study ID
- NCT07662694
- Run by
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- People needed
- 1100
- Starts
- 2026-07-01
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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