{"doc_desc":{"title":"Cohorte sur le risque de cancer apr\u00e8s cardiologie interventionnelle p\u00e9diatrique","idno":"FRESH-PEF6330-en","producers":[{"name":"Estelle RAGE","affiliation":"AUTORITE DE SURETE NUCLEAIRE ET DE RADIOPROTECTION (ASNR)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF6330-en","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":[]},"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":"Yes"},{"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"ionizing radiation"},{"keyword":"interventional cardiology"},{"keyword":"cancer"},{"keyword":"children"}],"topics":[{"topic":"Oncology","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":"Cardiology and vascular medicine","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":"Paediatrics","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":"Children with congenital heart disease frequently undergo cardiac catheterization procedures for diagnostic or treatment purposes. Despite the clear clinical benefit to the patient, the complexity of these procedures may result in high cumulative radiation exposure. Given children's greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study, named Coccinelle (Cohorte sur le risque de cancer apr\u00e8s cardiologie interventionnelle p\u00e9diatrique) is being launched in France to evaluate the risks of leukaemia and solid cancers in this specific population.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"The study population will include all children who have undergone at least one cardiac catheterization procedure since 2000 and were under 10 years old and permanent residents of France at the time of the procedure. Electronically stored patient records from the departments of paediatric cardiology of the French national network for complex congenital heart diseases (M3C) are being searched to identify the children to be included.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Socio-demographic data','Paraclinical data (non-biological) : Other']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"8000"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"30-05-2013","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":"No","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":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"The minimum dataset will comprise: identification of the subject, characteristics of the procedure and technical details, such as fluoroscopy time and dose area product (DAP), which are needed to reconstruct the doses received by each child. The cohort will be followed up through linkage with the two French paediatric cancer registries, which record all cases of childhood leukaemia and solid cancers in France. Radiation exposure will be estimated retrospectively for each child included in the cohort. Organ doses, especially to the lung, the oesophagus, and the thyroid will then be calculated with PCXMC software."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}