Clinical trial NCT03315468: French Clinical Datbase of Melanoma Patients (RIC-Mel)
Official title: French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma (Skin)
Keywords: melanoma
database
cohort
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: CENGEPS
name: Bristol-Myers Squibb
name: Hoffmann-La Roche
name: GlaxoSmithKline
name: Amgen
First posted: 2017-10-20
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient with melanoma disagreed to participate

Primary outcomes:
measure: Overall survival of melanoma patients included in the RIC-Mel database
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of melanoma patients included in the RIC-Mel database categorized by genders
timeFrame: through study completion, an average of 5 years
measure: Percentage of melanoma patients included in the RIC-Mel database categorized by histological subtypes
timeFrame: Day 1
measure: Percentage of melanoma patients included in the RIC-Mel database categorized by breslow thickness
timeFrame: day 1
measure: Percentage of melanoma patients included in the RIC-Mel database categorized by ulceration
timeFrame: day 1
measure: Percentage of melanoma patients included in the RIC-Mel database categorized by Melanoma stage
timeFrame: day 1
measure: Percentage of Participants With Mutation Status
timeFrame: Day 1
measure: Percentage of treatment types among melanoma stage
timeFrame: through study completion, an average of 5 years
measure: Progression-free survival of melanoma patients included in the RIC-Mel database
timeFrame: 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Brigitte DRENO, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: