Mucosal Melanoma of the Head and NeckCLASSIFY-OMMNCT07662694
CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
An observational study of Mucosal Melanoma of the Head and Neck and Oral Melanoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma of the Head and Neck, Oral Melanoma
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histopathologically confirmed primary oral mucosal melanoma
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,
Shanghai, Shanghai Municipality, 200011
Guoxin REN MD, MD, 13916948812, renguoxincn@sina.com
About this study
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.
Read the 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.
- Keywords
- Mucosal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Prospective Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
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.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal Melanoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ren guoxin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662694
- Sponsor's protocol ID
- SH9H-2026-T244-1
- Other IDs
- 2025DLC02
- Acronym
- CLASSIFY-OMM
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLASSIFY-OMM: Multicenter Rare Disease Cohort for T-Stage Reclassification and Molecular Subtyping-Based Precision Therapy in Oral Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT07662694
- Acronym / sponsor ID
- CLASSIFY-OMM / SH9H-2026-T244-1
- Keywords
- Mucosal Melanoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –Prospective Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histopathologically confirmed primary oral mucosal melanoma
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucosal Melanoma of the Head and Neck and Oral Melanoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Ren MD, MD (13916948812, renguoxincn@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.