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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mucosal Melanoma of the Head and Neck; Oral Melanoma

Detailed Description

Study Design This is a multicenter, bidirectional (retrospective + prospective) observational cohort study designed to establish a high-quality evidence platform for oral mucosal melanoma (OMM), a rare malignancy with high aggressiveness and poor prognosis. The study is conducted at four tertiary hospitals in China: Shanghai Ninth People's Hospital (lead center), Air Force Medical University Stomatological Hospital, Xiangya Hospital of Central South University, and Sun Yat-sen Memorial Hospital of Sun Yat-sen University.

Study Population The cohort will include a total of 1,100 Chinese patients with histopathologically confirmed primary OMM.

Retrospective cohort (n=800): Patients diagnosed between January 2015 and June 2025, with complete medical records, pathological slides, and available follow-up data.

Prospective cohort (n=300): Consecutive newly diagnosed patients enrolled from July 2025 to December 2028, after providing written informed consent.

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Guoxin REN MD, MD; Phone Number: 13916948812; Email: renguoxincn@sina.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
      • Contact: Guoxin REN MD, MD; Phone Number: 13916948812; Email: renguoxincn@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Histopathologically confirmed primary oral mucosal melanoma

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Retrospective Cohort; Prospective Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mucosal Melanoma
• Other Study ID Numbers: SH9H-2026-T244-1; 2025DLC02 (Other Grant/Funding Number: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No