French Clinical Datbase of Melanoma Patients (RIC-Mel)

NCT ID: NCT03315468

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-01

Study Completion Date

2030-03-01

Brief Summary

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With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.

To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :

RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.

To achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.

Detailed Description

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The RIC-Mel network federate clinicians researchers working in clinical and translational research for melanoma and carrying out patients inclusions in the clinical trials. These clinicians are working on clinical cancerology and dermatology sites located throughout the French national territory. Nowadays, the RIC-Mel network consists of 49 centers: 43 public dermatology centers (Hospital centers) and 6 private centers (Cancer centers). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris).

The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group of the French Society of Dermatology.

The RIC-Mel database has been approved by French health authorities, both ethically and for confidentiality of data (CCTIRS and CNIL). The database is available on the internet at any given moment thanks to a secure connection. All data are treated confidentially. The active file of patients with melanoma from each participating center is available in the database. All patients agreed to participate may be included in the database, regardless of their stage. Clinical data are collected thanks two forms :

* Part I key clinical data for any clinical trial Primary tumour (date of surgery, breslow…), lymph node removal (date, number of invaded lymph node…), AJCC stage, Mutation status, melanoma antigens, melanoma treatments (type, dates) and death.
* Part II: additional data for epidemiological and translational research Family history of melanoma, metastases (type, date of diagnosis…), HLA A and B type, additional information on treatments (dose, overall response, grade 3 or 4 side effects with the type, action on treatment and outcome).

In September 2017, more than 20,000 patients with melanoma had been included in the RIC-Mel database, with the following distribution: around 75% of primary stages (0 to II) and 25 % of metastatic stages (III and IV).

Conditions

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Melanoma (Skin)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient with melanoma, of any stage,
* Patient agreed to participate.

Exclusion Criteria

* Individuals under court protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CENGEPS

UNKNOWN

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaëlle Quereux, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gaëlle Quereux, PU-PH

Role: CONTACT

Amir Khammari

Role: CONTACT

Facility Contacts

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Gaëlle Quereux, PU-PH

Role: primary

Other Identifiers

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Prog 09/37-11

Identifier Type: -

Identifier Source: org_study_id

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