{"doc_desc":{"title":"Cohorte d'enfants sur l'\u00e9valuation du risque de cancer ou leuc\u00e9mie radio-induit","idno":"FRESH-PEF60187-fr","producers":[{"name":"Marie-odile BERNIER","affiliation":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60187-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60187"},{"agency":"FReSH","code":"FRESH-PEF60187"}]},"title":"Cohorte d'enfants sur l'\u00e9valuation du risque de cancer ou leuc\u00e9mie radio-induit","alternate_title":"ENFANT SCANNER"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Marie-Odile;BERNIER","PILabo":"LABORATOIRE D'EPID\u00c9MIOLOGIE (LEPID) INSTITUT DE RADIOPROTECTION ET DE S\u00dbRET\u00c9 NUCL\u00c9AIRE (IRSN)","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"09431862X","role":"pi 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(ASNR)","extlink":[{"title":"ORCID","uri":"0000-0003-1432-4738","role":"pi id"},{"title":"IdRef","uri":"156587181","role":"pi id"},{"title":"SIREN","uri":"130001803","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"dominique.laurier@irsn.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04dbtaf18","role":"sponsor id"},{"title":"SIREN","uri":"130001803","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EUROPEAN COMMISSION RESEARCH","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00k4n6c32"}]},{"name":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04dbtaf18"},{"title":"SIREN","uri":"130001803"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]}]},"distribution_statement":{"contact":[{"name":"Marie-Odile;BERNIER","email":"marie-odile.bernier@irsn.fr","type":"contact","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04dbtaf18","role":"organisation id","title":"ROR"},{"uri":"130001803","role":"organisation id","title":"SIREN"}]},{"name":"Sophie;JACOB","email":"sophie.jacob@irsn.fr","type":"contact","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04dbtaf18","role":"organisation id","title":"ROR"},{"uri":"130001803","role":"organisation id","title":"SIREN"}]},{"name":"Dominique;LAURIER","email":"dominique.laurier@irsn.fr","type":"contact","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04dbtaf18","role":"organisation id","title":"ROR"},{"uri":"130001803","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"leuc\u00e9mies"},{"keyword":"sant\u00e9"},{"keyword":"environnement"}],"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":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"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":"Objectif g\u00e9n\u00e9ral : le but de l\u2019\u00e9tude est d\u2019\u00e9valuer le risque de cancer ou de leuc\u00e9mie associ\u00e9 \u00e0 l\u2019utilisation du scanner au cours de la petite enfance (premier scanner r\u00e9alis\u00e9 entre 0 et 10 ans) et de quantifier la relation entre l'exposition aux rayonnements ionisants et la survenue des pathologies \u00e9tudi\u00e9es. Objectif secondaire : il s'agira aussi d'\u00e9tudier des facteurs modifiants \u00e9ventuels (\u00e2ge \u00e0 l\u2019exposition, sexe, etc..) de cette relation dose r\u00e9ponse.","abstract":"","coll_dates":[{"start":"2000-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion d\u2019enfants expos\u00e9s \u00e0 au moins un scanner pour une pathologie non cancer : - avant 5 ans pour la p\u00e9riode 2000-2006 - avant 10 ans pour la p\u00e9riode 2007-2013\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","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.Audit sur le traitement des bases de donn\u00e9es.L\\'IRSN est accr\u00e9dit\u00e9 ISO 9001.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) Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle)']"}},"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":"130 000"},"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":"Utilisation impossible des donn\u00e9es par des \u00e9quipes acad\u00e9miques et par des industriels","conditions":"","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":"26-06-2014","isContributorPI":"Non","contributorName":"Marie-odile BERNIER","contributorAffiliation":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28ENFANT+SCANNER+AND+%28Laurier+D[author]+OR+Bernier+MO[author]+OR+Jacob+S[author]%29%29+OR+25314057[uid]+OR+22190749[uid]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (Europe)","Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"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":"Recherche des cas de leuc\u00e9mies et cancers incidents dans la cohorte tous les 3 ans","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France via 20 centres"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es m\u00e9dicales : service prescripteur, donn\u00e9es PMSI","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"}