RIC-Mel Network - Network for Research and Clinical Investigation on Melanoma - French national cohort of

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1 RIC-Mel Network - Network for Research and Clinical Investigation on Melanoma - French national cohort of melanoma patients Head : Pr Dreno Brigitte, INSERM Unité U892 Equipe 2 «Recherche clinique et translationnelle des cancers cutanés» Pr Lebbe Céleste Last update : 10/25/2017 Version : 3 ID : 5135 General Identification Detailed name Sign or acronym CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Network for Research and Clinical Investigation on Melanoma - French national cohort of melanoma patients RIC-Mel Network CNIL: EGY/EM/AR General Aspects Medical area Pathology (details) Keywords Cancer research Dermatology, venereology Melanoma Melanoma, network, cohort, epidemiology, preclinical to phase III studies, national, european and international instances, fondamental and translational research. Collaborations Participation in projects, networks and consortia Details Our partners : the Cancerology Group (GCC) of the French Society of Dermatology (SFD), the clinico-biologico-radiological database MELBASE, the Ile de France Melanoma network, the Far West Biotherapies and Researches in Dermatology network (BIORDERM), the West Melanoma Network and the patients association AMESA. Funding

2 Funding Funding status Mixed Details - Governance of the database Sponsor(s) or organisation(s) responsible Organisation status Sponsor(s) or organisation(s) responsible Organisation status Presence of scientific or steering committees CHU de Nantes - RIC-Mel coordinating center Public Cancerology Group (GCC) of the French Society of Dermatology (SFD) Public Scientific investigator(s) (Contact) Name of the director Surname Address Pr Dreno Brigitte CHU de Nantes Service de Dermatologie Site Hôtel Dieu 1, place Alexis Ricordeau Nantes cedex 01 Phone + 33 (0) Unit Organization Name of the director Surname Address brigitte.dreno@wanadoo.fr INSERM Unité U892 Equipe 2 «Recherche clinique et translationnelle des cancers cutanés» INSERM - Institut National de la Santé et de la Recherche Pr Lebbe Céleste Assistance Publique des Hôpitaux de Paris Hôpital Saint Louis Service de Dermatologie 1, avenue Claude Vellefaux Paris

3 Phone + 33 (0) Organization celeste.lebbe@sls.aphp.fr Hôpital Saint-Louis (AP-HP) Additional contact Main features Type of database Type of database Study databases (details) Database recruitment is carried out by an intermediary Database recruitment is carried out as part of an interventional study Additional information regarding sample selection. Study databases Cohort study A selection of health institutions and services After 5 and a half years in existence, more than 20,000 patients have been included in database by our 49 participating centers. Database objective Main objective Inclusion criteria - To federate the clinical cancerology and dermatology sites as well as the existing networks in melanoma around a common database, - To be a preferred interlocutor for the industry, - To ensure close interaction between all the hospital disciplines involved in melanoma evolution, - To ensure the functioning of a clinica ldatabase, - To ensure interactions between clinical and translational research as well as to support basic research. Patients with melanoma, regardless of the stage, and who have accepted to participate. Population type Age Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years)

4 Great age (80 years and more) Population covered Pathology Gender Geography area Detail of the geography area Sick population C00-C97 - Malignant neoplasms Male Woman National France Data collection Dates Date of first collection (YYYY or MM/YYYY) March 2012 Size of the database Size of the database (number of individuals) Details of the number of individuals Greater than individuals patients (2 October, 2017) Data Database activity Type of data collected Clinical data (detail) Details of collected clinical data Presence of a biobank Health parameters studied Current data collection Clinical data Direct physical measures Medical registration Data relating to the primitiv tumour, disease evolution (stage, treatments...) until death. Health event/morbidity Health event/mortality Procedures Data collection method Participant monitoring Data are collected during patient follow-up, after expressing its consent

5 Details on monitoring of participants Links to administrative sources Patients come as part of their usual medical care. The updating of data only occurs in case of disease progression (change in the stage and/or in the treatment). Promotion and access Promotion Description Description Publications_Pr_Brigitte_Dreno.pdf Plaquette_informative_du_réseau_RIC- Mel_version_anglaise,RIC-Mel-DI-003,v.04.pdf Book_académique_RIC-Mel_CID_2016.pdf Academic book oh the RIC-Mel network created for the Cohort Innovation Day 2016, organised byaviesan and ARIIS with the support of INSERM Transfert Poster_ESDR_2015_Réseau-RIC- Mel_ pdf Poster presented at the annual congress of the European Society for Dermatological Research in 2015, and selected for the Poster walks (Cancer) Access Presence of document that lists variables and coding procedures Please contact : Terms of data access (charter for data provision, format of data, availability delay) Access to aggregated data Access to individual data Mr Amir KHAMMARI Deputy coordinator of the RIC-Mel network Tel. : Mail : amir.khammari@chu-nantes.fr Mrs Emilie VAREY Project manager of the RIC-Mel network Tel. : Mail : emilie.varey@chu-nantes.fr Access on specific project only access