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NCT07662694Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1100 (estimated)
First submitted
17 Jun 2026
Start date
1 Jul 2026
Primary completion date
30 Dec 2028
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Diseases
Melanoma
NCT number
NCT07662694

What you commit to

  • Study type: Observational
  • Planned participants: 1100
  • From 1 Jul 2026 to the primary completion date, 30 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Coordinator of this site? Confirm its status		ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.