Molecular Characterization of Primary Mucosal Melanoma | NCT03319693

Studies
Molecular Characterization of Primary Mucosal Melanoma

NCT03319693

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Aug 22, 2024Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Mucosal Melanoma

Interventions

Somatic Genetic

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2017Actual

Primary Completion Date

Apr 28, 2019Actual

Completion Date

Apr 28, 2021Actual

First Submitted Date

Oct 20, 2017

First Submission Date that Met QC Criteria

Oct 23, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. " 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mucosal melanoma		Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014	Genetic: Somatic Genetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatic Genetic	Genetic	NGS analysis	Mucosal melanoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The frequency of main mutations identified using the NGS panel	NGS panel	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014

Exclusion criteria:

Cutaneous melanoma
Uveal melanoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with MPM

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Chu Reims		Reims		51092	France

Intervention Browse Module

MeSH Terms

ID	Term
D015316	Genetic Therapy

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics
D005818	Genetic Engineering
D005821	Genetic Techniques

Browse Leaves

Not provided

Browse Branches

Not provided