{"doc_desc":{"title":"R\u00e9seau pour la Recherche et l'Investigation Clinique sur le M\u00e9lanome - Cohorte nationale de patients atteints de m\u00e9lanome","idno":"FRESH-PEF5135-fr","producers":[{"name":"Brigitte DRENO","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5135-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5135"},{"agency":"FReSH","code":"FRESH-PEF5135"}]},"title":"R\u00e9seau pour la Recherche et l'Investigation Clinique sur le M\u00e9lanome - Cohorte nationale de patients atteints de m\u00e9lanome","alternate_title":"R\u00e9seau RIC-Mel"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Brigitte;DRENO","PILabo":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ORCID","uri":"0000-0001-5574-5825","role":"pi id"},{"title":"IdRef","uri":"06094370X","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Brigitte.Dreno@univ-nantes.fr","isContact":"Oui"},{"type":"investigator","name":"Emilie;VAREY","PILabo":"","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"27883020X","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"emilie.varey@chu-nantes.fr","isContact":"Oui"}],"oth_id":[{"name":"Nos partenaires : le Groupe de Canc\u00e9rologie Cutan\u00e9 (GCC) de la Soci\u00e9t\u00e9 Fran\u00e7aise de Dermatologie (SFD), la base clinico-biologico-radiologique MELBASE, le r\u00e9seau M\u00e9lanome Ile de France, le r\u00e9seau Grand Ouest de Bioth\u00e9rapies et Recherche en Dermatologie (BIORDERM), l'association de patients M\u00e9lanome Sans Angoisse (AMESA)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SOCIETE FRAN\u00c7AISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03gck1m55","role":"sponsor id"}],"role":"sponsor"},{"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":""}]},"distribution_statement":{"contact":[{"name":"C\u00e9leste;LEBBE","email":"celeste.lebbe@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Brigitte;DRENO","email":"Brigitte.Dreno@univ-nantes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]},{"name":"Emilie;VAREY","email":"emilie.varey@chu-nantes.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"M\u00e9lanome"},{"keyword":"r\u00e9seau"},{"keyword":"cohorte"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"phases pr\u00e9-cliniques aux phases III"},{"keyword":"instances nationales"},{"keyword":"europ\u00e9ennes et internationales"},{"keyword":"recherche fondamentale et translationnelle."}],"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"}]},{"topic":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]}],"purpose":"- F\u00e9d\u00e9rer les centres cliniques de dermatologie et de canc\u00e9rologie, ainsi que les r\u00e9seaux existant dans le domaine du m\u00e9lanome autour d'une base de donn\u00e9es commune, - Etre un interlocuteur privil\u00e9gi\u00e9 pour les industriels, - Assurer des interactions \u00e9troites avec l'ensemble des disciplines hospitali\u00e8res intervenant dans l'\u00e9valuation du m\u00e9lanome, - Assurer le fonctionnement d'une base de donn\u00e9es clinique nationale, - Assurer les interactions entre recherche clinique et translationnelle, et soutenir la recherche fondamentale.","abstract":"","coll_dates":[{"start":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients atteints de m\u00e9lanome de toute origine (cutan\u00e9s, muqueux, oculaires ou inconnu) et de tout stade, ayant accept\u00e9 de participer (recueil de la non-opposition).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Mise en place d\\'un Syst\u00e8me Management de la Qualit\u00e9 (diffusion et usage interne).']"}},"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":">= 20000 individus","response_rate":"27 251 patients inclus au 12 octobre 2020"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"04-02-2021","isContributorPI":"Non","contributorName":"Brigitte DRENO","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es sont recueillies dans le cadre du suivi du patient, apr\u00e8s expression de sa non-opposition.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es sur la tumeur primitive, l'\u00e9volution de la maladie (stade, statut mutationnel...), prise en charge th\u00e9rapeutique. Le suivi du patient est r\u00e9alis\u00e9 jusqu'\u00e0 son d\u00e9c\u00e8s.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}