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

NCT07662694 | Not Yet Recruiting DMC

• 2 other identifiers: SH9H-2026-T244-12025DLC02
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucosal Melanoma of the Head and Neck; Oral Melanoma

Keywords

Mucosal Melanoma

Outcome Measures

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.

  24months

Study Arms (1)

Retrospective Cohort

Prospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Histopathologically confirmed primary oral mucosal melanoma

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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,

Shanghai, Shanghai Municipality, 200011, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tumor

Central Study Contacts

Guoxin Ren MD, MD

CONTACT

13916948812; renguoxincn@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CN (1)