CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma

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.

NCT Number	NCT07662694
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions	Mucosal Melanoma of the Head and Neck, Oral Melanoma
Enrollment	1,100 participants
Start Date	2026-07-01
Primary Completion	2028-12-30 (estimated)
Study Completion	2029-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-23