Not Yet RecruitingNot Applicable

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

China1,100 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

overall survival

Timeframe: 24months

Trial details

NCT IDNCT07662694

SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-30

Contact for this trial

Guoxin Ren MD, MD

13916948812 renguoxincn@sina.com

View on ClinicalTrials.gov More Mucosal Melanoma of the Head and Neck trials