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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histopathologically confirmed primary oral mucosal melanoma (WHO criteria);

Disqualifiers

Primary melanoma originating from skin, eye, esophagus, or other non-oral mucosal sites;

Trial population

Histopathologically confirmed primary oral mucosal melanoma

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,100 Participants
are grouped into 1 trial group
Group A: Retrospective Cohort

Trial outcomes

Primary outcomes

1

overall survival

OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

Time frame
24months

Secondary outcomes

Other outcomes

Sponsors and contacts

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