{"doc_desc":{"title":"Cohorte d'enfants: \u00e9tude des risques iatrog\u00e8nes associ\u00e9s aux examens scanners re\u00e7us dans l\u2019enfance","idno":"FRESH-PEF5108-fr","producers":[{"name":"Florent DE VATHAIRE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5108-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5108"},{"agency":"FReSH","code":"FRESH-PEF5108"}]},"title":"Cohorte d'enfants: \u00e9tude des risques iatrog\u00e8nes associ\u00e9s aux examens scanners re\u00e7us dans l\u2019enfance","alternate_title":"TOMENF"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"type":"investigator","name":"Florent;DE VATHAIRE","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche \/ Equipe-3 d\u2019Epid\u00e9miologie des radiations- CESP- UMR 1018 INSERM","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-8374-9281","role":"pi id"},{"title":"IdRef","uri":"035018852","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"florent.devathaire@gustaveroussy.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"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":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Florent;DE VATHAIRE","email":"florent.devathaire@gustaveroussy.fr","type":"contact","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":"examen tomodensitom\u00e9trique"},{"keyword":"exposition m\u00e9dicale"},{"keyword":"scanner"},{"keyword":"relation dose re\u00e7ue \u00e0 l'organe-effet"},{"keyword":"effets iatrog\u00e8nes des radiations"},{"keyword":"faibles doses de radiations ionisantes"},{"keyword":"maladie cardiovasculaire"},{"keyword":"maladie c\u00e9r\u00e9brovasculaire"},{"keyword":"dosim\u00e9trie"},{"keyword":"enfance"},{"keyword":"facteurs de risque"},{"keyword":"cohorte"}],"topics":[{"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":"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":"Tumeurs malignes de localisations primitives mal d\u00e9finies ou non pr\u00e9cis\u00e9es","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1594217552","title":"CIM-11"}]},{"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":"L'objectif g\u00e9n\u00e9ral est de constituer et d'actualiser le suivi des sujets afin de pouvoir d\u00e9crire et \u00e9tudier l'ensemble des effets iatrog\u00e8nes \u00e9ventuels apr\u00e8s exposition \u00e0 des examens scanners re\u00e7us dans l'enfance par le biais d\u2019une \u00e9tude de cohorte. Les principaux objectifs de la mise en place de la cohorte sont : -d'identifier un \u00e9ventuel risque de cancer radio-induit apr\u00e8s examen tomodensitom\u00e9trique dans l'enfance, et le quantifier s'il existe; -d'identifier les facteurs modifiant cet \u00e9ventuel risque, \u00e0 savoir, la relation avec la dose re\u00e7ue par l'organe, le pourcentage de l'organe irradi\u00e9, l\u2019\u00e2ge \u00e0 l'examen, le sexe et \u00e9ventuellement d\u2019autres facteurs canc\u00e9rog\u00e8nes. Les objectifs secondaires sont d\u2019identifier des \u00e9ventuels risques d'autres pathologies radio-induites telles que c\u00e9r\u00e9bro et cardio-vasculaire, et les quantifier s'ils existent.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"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\": \"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\": \" enfant \u00e2g\u00e9 de moins de 15 ans \u00e0 la date du 1er examen - examen r\u00e9alis\u00e9 pour un motif autre qu'une suspicion de tumeur - examen r\u00e9alis\u00e9 dans la p\u00e9riode 1998-2008  - enfant ayant sa r\u00e9sidence principale en France au moment de l'examen\",\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":""}},"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":"[10000-20000[ individus","response_rate":"11 000"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Cette \u00e9tude est la partie fran\u00e7aise d'une \u00e9tude internationale (CHILD-MED-RAD: Cohort studies of children with substantial medical diagnostic exposures). Le Centre International de Recherches sur le Cancer (CIRC) de l\u2019OMS \u00e0 Lyon a acc\u00e8s aux donn\u00e9es non nominatives."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"13-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"14-08-2013","isContributorPI":"Non","contributorName":"Florent DE VATHAIRE","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (Europe)","Industrie","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":"La cohorte est constitu\u00e9e par consultation des fichiers informatis\u00e9s des centres de radiologie participants. Les donn\u00e9es d'identification et anthropom\u00e9triques, le motif de l'examen et les donn\u00e9es dosim\u00e9triques sont recueillies afin de r\u00e9liser estimation de la dosim\u00e9trie. La cohorte est ensuite aliment\u00e9e par consultation et croisement de bases m\u00e9dico-administratives renseignant sur le statut vital, les causes des \u00e9ventuels d\u00e9c\u00e8s et les cas de cancers. La m\u00e9thodologie retenue est celle d\u2019une \u00e9tude de cohorte r\u00e9trospective avec un suivi prospectif.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"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"}