{"doc_desc":{"title":"Cohorte de 5000 patients \u00e0 risque de m\u00e9lanome","idno":"FRESH-PEF60197-fr","producers":[{"name":"Jean-Michel NGUYEN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60197-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60197"},{"agency":"FReSH","code":"FRESH-PEF60197"}]},"title":"Cohorte de 5000 patients \u00e0 risque de m\u00e9lanome","alternate_title":"COPARIME 5000"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Ga\u00eblle;QUEREUX","PILabo":"CHU \/ UNIT\u00c9 ONCODERMATOLOGIE- UMR892 UNIT\u00c9 ONCODERMATOLOGIE- UMR892","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0002-1739-1701","role":"pi id"},{"title":"IdRef","uri":"144285177","role":"pi id"},{"title":"","uri":"","role":"organisation id"},{"title":"RNSR","uri":"202023527R","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Jean-Michel;NGUYEN","PILabo":"CHU \/ SERVICE D'EPID\u00c9MIOLOGIE ET DE BIOSTATISTIQUES- CHU NANTES UMR892 ET CHU DE NANTES","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0001-8815-7640","role":"pi id"},{"title":"IdRef","uri":"087292335","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"202023527R","role":"labo id"}],"email":"Jean-Michel.Nguyen@univ-nantes.fr","isContact":"Oui"},{"type":"investigator","name":"C\u00e9dric;RAT","PILabo":"UNIVERSITE DE \/ D\u00c9PARTEMENT DE M\u00c9DECINE G\u00c9N\u00c9RAL","affiliationName":"NANTES UNIVERSITE","extlink":[{"title":"ORCID","uri":"0000-0003-4556-4494","role":"pi id"},{"title":"IdRef","uri":"106997106","role":"pi id"},{"title":"SIREN","uri":"130029747","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cedric.rat@univ-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Jean-Michel;NGUYEN","email":"Jean-Michel.Nguyen@univ-nantes.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]},{"name":"C\u00e9dric;RAT","email":"cedric.rat@univ-nantes.fr","type":"contact","affiliationName":"NANTES UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03gnr7b55","role":"organisation id","title":"ROR"},{"uri":"130029747","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"maladies malignes"},{"keyword":"d\u00e9ficits immunitaires"},{"keyword":"usagers"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"maladies auto-immunes"},{"keyword":"pr\u00e9vention"},{"keyword":"syst\u00e8me de sant\u00e9"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : estimer le risque de d\u00e9veloppement de novo d'un m\u00e9lanome cutan\u00e9 pour une population \u00e0 risque selon le SAM score (Self Administrated Melanoma risk score). Evaluer la faisabilit\u00e9 d\u2019un d\u00e9pistage cibl\u00e9 sur une population \u00e0 haut risque de m\u00e9lanome par l\u2019estimation du rapport du nombre de m\u00e9lanomes d\u00e9pist\u00e9s \/ nombre de patients \u00e0 haut risque de m\u00e9lanome d\u00e9finis par notre outil de s\u00e9lection Objectif secondaire : - D\u00e9crire les caract\u00e9ristiques \u00e9pid\u00e9miologiques et cliniques des patients. - Constituer une bioth\u00e8que afin de faciliter la r\u00e9alisation d'\u00e9tudes sur ces maladies et d\u2019\u00e9tudier les m\u00e9canismes physiopathog\u00e9niques, h\u00e9mato-immunologiques et g\u00e9n\u00e9tiques de ces maladies. - \u00c9laborer et valider des recommandations th\u00e9rapeutiques nationales, selon les sous groupes \u00e9ventuels de patients.","abstract":"","coll_dates":[{"start":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la 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patient ou retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le 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