{"doc_desc":{"title":"Cohorte de patients atteints de m\u00e9lanome","idno":"FRESH-PEF60100-fr","producers":[{"name":"Philippe SAIAG","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60100-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60100"},{"agency":"FReSH","code":"FRESH-PEF60100"}]},"title":"Cohorte de patients atteints de m\u00e9lanome","alternate_title":"MELAN-COHORT"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Philippe;SAIAG","PILabo":"APHP \/ EA 4339 PEAU CANCER ENVIRONNEMENT APHP, UVSQ","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-6500-3507","role":"pi id"},{"title":"IdRef","uri":"167286242","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.saiag@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE FRAN\u00c7AISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03gck1m55"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"REGION ILE DE FRANCE","extlink":[{"title":"SIREN","uri":"237500079"}]}]},"distribution_statement":{"contact":[{"name":"Philippe;SAIAG","email":"philippe.saiag@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"}]}]},"study_info":{"keywords":[{"keyword":"disease-free survival"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"overall survival"},{"keyword":"tumeur"}],"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"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : constituer la plus grande cohorte prospective de patients atteints de m\u00e9lanome avec biobanques tissus et de sang en Europe Objectif secondaire : constituer une \u00e9quipe de recherche de cliniciens, pathologistes, g\u00e9n\u00e9ticiens, des chercheurs en sciences fondamentales, afin d'obtenir une r\u00e9activit\u00e9 de recherche de haute qualit\u00e9","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2018-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Les crit\u00e8res d'inclusion sont: (i) m\u00e9lanome confirm\u00e9 histologiquement, (ii) m\u00e9lanome cutan\u00e9 primitif recouvrable (iii) m\u00e9lanome primaire trait\u00e9 par ex\u00e9r\u00e8se chirurgicale avec une marge de peau saine \u00e0 partir d'au moins 1 ou 2 cm selon l'\u00e9paisseur du m\u00e9lanome, (iv) au moins 18 ans, (v) r\u00e9sidence en \u00eele -de-France zone, (vi) * Absence d'une autre pathologie affectant le pronostic vital.  La date d'entr\u00e9e dans la cohorte est uniforme: dans les 3 mois qui suivent l'ex\u00e9r\u00e8se chirurgicale du m\u00e9lanome initial, dans les 3 mois qui suivent la chirurgie ganglionnaire dans le cas de l'extension ganglionnaire, dans le mois qui suit le diagnostic de (m\u00e9tastases en transit ou \u00e0 distance).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour au dossier source ou retour vers le patient ou retour vers un tiersRelance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audit qualit\u00e9 : Audits internes Fr\u00e9quence audit interne : MONITORING DE TOUS LES DOSSIERS CLINIQUES, PASSAGE DANS CHAQUE CENTRE AU MOINS BI-MENSUEL Autre(s) proc\u00e9dure(s) qualit\u00e9 : VERIFICATIONS REGULIERES QUALITE ADN ET ARN, BIOBANQUES CONFORMES REGLEMENTATION, 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 participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1250"},"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 r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels ? Oui","conditions":"Condition d'acc\u00e8s soumission projet au comite de pilotage, appreciation quantites consommees, etablissement \u00ab material supply and collaboration agreement \u00bb si partenaire hors melan-cohort Condition d'acc\u00e8s soumission projet au comite de pilotage, appreciation quantites consommees, etablissement \u00ab material supply and collaboration agreement \u00bb avec la drcd","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"13-08-2014","isContributorPI":"Non","contributorName":"Philippe SAIAG","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=melan-cohort+OR+melancohort"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) Examens cliniques : Etape manuscrite (Saisie manuelle) Examens biologiques : Etape manuscrite (Saisie manuelle)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"ILE DE FRANCE"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Tumeur primaire, ganglion sentinelle, m\u00e9tastases autres. Dans le sang, ADN, ARN, plasma, serum, PBMC, prot\u00e9omique","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}