CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma (CLASSIFY-OMM)
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Guoxin REN MD, MD
- Telefonnummer: 13916948812
- E-post: renguoxincn@sina.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200011
- the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
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Ta kontakt med:
- Guoxin REN MD, MD
- Telefonnummer: 13916948812
- E-post: renguoxincn@sina.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Retrospektiv årskull
Potensiell årskull
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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overall survival
Tidsramme: 24months
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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.
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24months
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- SH9H-2026-T244-1
- 2025DLC02 (Annet stipend/finansieringsnummer: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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