{"doc_desc":{"title":"Cohorte sur le risque de cancer apr\u00e8s cardiologie interventionnelle p\u00e9diatrique","idno":"FRESH-PEF6330-fr","producers":[{"name":"Estelle RAGE","affiliation":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6330-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"6330"},{"agency":"FReSH","code":"FRESH-PEF6330"}]},"title":"Cohorte sur le risque de cancer apr\u00e8s cardiologie interventionnelle p\u00e9diatrique","alternate_title":"Coccinelle"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"H\u00e9l\u00e8ne;BAYSSON","PILabo":"IRSN \/ Laboratoire d'Epid\u00e9miologie","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"130001803","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"helene.baysson@irsn.fr","isContact":"Oui"},{"type":"investigator","name":"Marie-Odile;BERNIER","PILabo":"IRSN \/ Laboratoire d'Epid\u00e9miologie","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"09431862X","role":"pi id"},{"title":"SIREN","uri":"130001803","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"marie-odile.bernier@irsn.fr","isContact":"Oui"},{"type":"investigator","name":"Dominique;LAURIER","PILabo":"IRSN \/ Laboratoire d'Epid\u00e9miologie","affiliationName":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (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":""}],"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":"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"}]}]},"distribution_statement":{"contact":[{"name":"H\u00e9l\u00e8ne;BAYSSON","email":"helene.baysson@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":"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":"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":"rayonnements ionisants"},{"keyword":"enfants"}],"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":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"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"}]}],"purpose":"Constituer une cohorte d\u2019enfants de moins de 10 ans ayant b\u00e9n\u00e9fici\u00e9 d\u2019au moins une proc\u00e9dure de cardiologie interventionnelle entre 2000 et 2013 afin d\u2019\u00e9valuer les risques de cancer \u00e0 long terme","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2014-01-01"}],"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Les enfants ayant b\u00e9n\u00e9fici\u00e9 d\u2019une proc\u00e9dure de cardiologie interventionnelle entre 2000 et 2013 et \u00e2g\u00e9s de moins de 10 ans au moment de l\u2019intervention de cardiologie.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Autre']","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.']"}},"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":"[1000-10000[ individus","response_rate":"8000"},"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":"","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":"30-05-2013","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":"Non","contributorName":"Estelle RAGE","contributorAffiliation":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28%28Baysson[Author]+OR+Bernier[Author]+OR+Laurier[Author]%29+AND+%28coccinelle+OR+ladybird%29%29+OR+23521893[uid]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"R\u00e9trospectif","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"centres de cardiologie p\u00e9diatrique ayant une activit\u00e9 de cardiologie interventionnelle"},"dataTypes":{"clinicalDataDetails":"-------","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"}