{"study_desc":{"title_statement":{"idno":"FRESH-PEF5817-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5817"},{"agency":"FReSH","code":"FRESH-PEF5817"}]},"title":"Cohorte du cancer de la thyro\u00efde","alternate_title":"VENUS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Florent;DE VATHAIRE","firstname":"Florent","lastname":"DE VATHAIRE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"0000-0002-8374-9281","role":"pi id","title":"ORCID"},{"uri":"035018852","role":"pi id","title":"IdRef"}],"email":"florent.devathaire@gustaveroussy.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche \/ Equipe 3 \u00c9pid\u00e9miologie des cancers : radiocarcinogen\u00e8se et effets iatrog\u00e8nes des traitementsUMR 1018 Center for research in epidemiology and population health (CESP)","isContact":true},{"name":"Carole;RUBINO","firstname":"Carole","lastname":"RUBINO","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"uri":"255164467","role":"pi id","title":"IdRef"}],"email":"carole.rubino@gustaveroussy.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche \/ Equipe 3 \u00c9pid\u00e9miologie des cancers : radiocarcinogen\u00e8se et effets iatrog\u00e8nes des traitementsUMR 1018 Center for research in epidemiology and population health (CESP)","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EUROPEAN COMMISSION RESEARCH","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00k4n6c32"}]},{"name":"ELECTRICITE DE FRANCE (EDF)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03wb8xz10"},{"title":"SIREN","uri":"552081317"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]}]},"distribution_statement":{"contact":[{"name":"Florent;DE VATHAIRE","lastname":"DE VATHAIRE","firstname":"Florent","type":"contact","email":"florent.devathaire@gustaveroussy.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Carole;RUBINO","lastname":"RUBINO","firstname":"Carole","type":"contact","email":"carole.rubino@gustaveroussy.fr","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Cancers radio-induits"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"devenir des grossesses."}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"\u00c9tudier le devenir m\u00e9dical \u00e0 long terme et la descendance des patients trait\u00e9s pour un cancer de la thyro\u00efde. Objectif secondaire : - Estimer la relation entre l'activit\u00e9 d'iode 131 re\u00e7ue durant le traitement d'un cancer de la thyro\u00efde et le risque de cancer ou de leuc\u00e9mie secondaire ; - Estimer le r\u00f4le du d\u00e9bit de dose dans le risque de cancer radio-induit.","abstract":"","coll_dates":[{"start":"1992-01-01","end":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Adolescence (13 \u00e0 18 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}},{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Sujets ayant re\u00e7u un traitement pour un cancer de la thyro\u00efde entre 1950 et 2000 dans un des centres participant \u00e0 l'\u00e9tude.\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques (hors biologiques)','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou par retour vers le patient.Les patients sont inform\u00e9s de l'utilisation de leur donn\u00e9es par \u00e9crit.']"}},"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\r\nConsommation de soins\/services de sant\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":"[10000-20000[ individus","response_rate":"15500"},"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\"}]}","notes":""},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques ou par des industriels","conditions":"Apr\u00e8s discussion avec les responsables, v\u00e9rification de la coh\u00e9rence du projet, en partenariat avec les \u00e9quipes participantes.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"24-04-2013","lastUpdatedManual":"05-09-2017","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/HAL-VENUS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (Europe)","Industrie","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie manuelle \u00e0 partir d\u2019un questionnaire papier.Entretiens : saisie manuelle \u00e0 partir d\u2019un questionnaire papier.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France :- IGR Villejuif,- Institut Jean Godinot de Reims,- Centre Antoine Baclesse de Caen,- Centre Ren\u00e9 Huguenin Saint Cloud - service de m\u00e9decine radionucl\u00e9aire.Italie :- Busto Arsizio - d\u00e9partement de m\u00e9decine nucl\u00e9aire.Su\u00e8de- Karolinska institute"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi P\u00e9riodicit\u00e9 de l'examen selon le suivi du patientActualisation des donn\u00e9es depuis la fin de la cohorte r\u00e9trospective (31\/12\/2006). Informations recueillies lors de l'examen clinique : Recueil de donn\u00e9es m\u00e9dicales issues du dossier cliniques et radiologiques : - caract\u00e9ristiques du cancer de la thyro\u00efde, - diagnostic \u00e9ventuel de tumeur secondaire, - \u00e9v\u00e9nements li\u00e9s au 1er cancer, - traitements re\u00e7us.","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}