Mucosal MelanomaMELMUQNCT03319693
Molecular Characterization of Primary Mucosal Melanoma
An observational study of Mucosal Melanoma, run by CHU de Reims at 1 site in France.
Trial summary
Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucosal Melanoma
- What is being tested?
- Somatic Genetic
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2017to 28 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with MPM
Who may be able to join
- Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014
Who cannot join
- Cutaneous melanoma
- Uveal melanoma
Trial locations and contacts
1 site in 1 country.
About this study
Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.
The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.
- Conditions
- Mucosal Melanoma
- Being tested
- Somatic Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic GeneticGenetic
NGS analysis
| Study group | Role | What they receive |
|---|---|---|
| Mucosal melanoma | Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014 Receives: Genetic: Somatic Genetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of main mutations identified using the NGS panel
NGS panel
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start28 Aug 2017
- Primary completion28 Apr 2019
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal MelanomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319693
- Sponsor's protocol ID
- PA16108*
- Acronym
- MELMUQ
- Status last verified
- Aug 2024
- First submitted
- 20 Oct 2017
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Primary Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT03319693
- Acronym / sponsor ID
- MELMUQ / PA16108*
- Conditions
- Mucosal Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 24 Oct 2017 (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.
Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.
The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucosal melanoma | – | Genetic: Somatic GeneticIncident Mucosal melanoma in the Champagne-Ardenne region 2004-2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MPM
Key inclusion criteria (1 listed)
- Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014
Key exclusion criteria (2 listed)
- Cutaneous melanoma
- Uveal melanoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic GeneticNGS analysis | Genetic | Mucosal melanoma |
Primary outcome
The frequency of main mutations identified using the NGS panel
Time frame: Day 0
NGS panel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by CHU de Reims at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Aug 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of main mutations identified using the NGS panel (time frame: Day 0). 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 22 Aug 2024.