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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07662694

Acronym

CLASSIFY-OMM

Enrollment

1100

Registered

2026-06-23

Start date

2026-07-01

Completion date

2029-12-30

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucosal Melanoma of the Head and Neck, Oral Melanoma

Keywords

Mucosal Melanoma

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
overall survival	24months	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.

Countries

China

Contacts

CONTACTGuoxin Ren MD, MD

renguoxincn@sina.com13916948812

Outcome results