Clinical trial · Observational
CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucosal Melanoma of the Head and Neck | Head and Neck Mucosal Melanoma | ALIAS | 0.90 |
| Oral Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Retrospective Cohort
- description
- Prospective Cohort
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 24months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available