Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Observational
Started
2026-07-01
Last updated
2026-06-23
Condition(s) studied
Mucosal Melanoma of the Head and NeckOral Melanoma
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai
Shanghai Municipality
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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