{"doc_desc":{"title":"Registre des Malformations Cong\u00e9nitales de Paris (registre qualifi\u00e9 2013-2016)","idno":"FRESH-PEF221-fr","producers":[{"name":"Babak KHOSHNOOD","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF221-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"221"},{"agency":"FReSH","code":"FRESH-PEF221"}]},"title":"Registre des Malformations Cong\u00e9nitales de Paris (registre qualifi\u00e9 2013-2016)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Babak;KHOSHNOOD","PILabo":"Inserm \/ U953","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-4031-4915","role":"pi id"},{"title":"IdRef","uri":"167278525","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"babak.khoshnood@inserm.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"},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"Babak;KHOSHNOOD","email":"babak.khoshnood@inserm.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":"anomalies cong\u00e9nitales diagnostic pr\u00e9natal"}],"topics":[{"topic":"Trouble du jeu de hasard, principalement en ligne","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1939508018","title":"CIM-11"}]}],"purpose":"1. Assurer la surveillance \u00e9pid\u00e9miologique des anomalies cong\u00e9nitales dans la population parisienne, avec un objectif d'alerte face \u00e0 d'\u00e9ventuels agents t\u00e9ratog\u00e8nes de l'environnement (ex : m\u00e9dicament, accident industriel), et ceci \u00e0 l'\u00e9chelon local, national et international. En cas de variation anormale de fr\u00e9quence d'une anomalie, des investigations compl\u00e9mentaires sont entreprises, avec la recherche de facteurs de risque particuliers, mais aussi de biais d'enregistrement ou de recrutement susceptibles d'aboutir \u00e0 une fausse alarme. 2. Evaluer en population l'impact des actions de sant\u00e9: - L'\u00e9valuation du d\u00e9pistage pr\u00e9natal des malformations est un objectif fondamental du registre, et ce d'autant plus que ce d\u00e9pistage s'est consid\u00e9rablement d\u00e9velopp\u00e9 en France depuis les ann\u00e9es 80. - L'\u00e9valuation des actions de pr\u00e9vention est \u00e9galement importante, et notamment celle de l'impact de la politique de pr\u00e9vention primaire des anomalies de fermeture du tube neural par suppl\u00e9mentation p\u00e9riconceptionnelle en acide folique, mise en place en France \u00e0 partir de l'ann\u00e9e 2000. 3. R\u00e9aliser des \u00e9tudes en collaboration avec les services cliniques sp\u00e9cialis\u00e9s, en particulier pour l'\u00e9valuation en population du devenir des enfants porteurs de certaines malformations invalidantes. 4. Contribuer \u00e0 la recherche \u00e9tiologique, notamment dans le cadre d'\u00e9tudes collaboratives multicentriques pour les malformations rares. Il peut encore s'agir d'\u00e9tudes cas-t\u00e9moins ou de cohortes mises en place \u00e0 partir de questions de recherche particuli\u00e8res.","abstract":"","coll_dates":[{"start":"1981-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Le Registre recense les cas de malformations et d\u2019anomalie chromosomiques parmi les naissances vivantes, les mort-n\u00e9s (de 22 semaines d\u2019am\u00e9norrh\u00e9e ou plus), ainsi que les IMG quel qu\u2019en soit l\u2019\u00e2ge gestationnel.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":">= 20000 individus","response_rate":"1981-2008: more than 34 000 cases 2008 : 1409 cases"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"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":"acc\u00e8s aux donn\u00e9es anonymis\u00e9es possible avec un protocole de l'\u00e9tude approuv\u00e9 par l'\u00e9quipe du Registre et l'unit\u00e9 953 de l'Inserm","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":"29-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"16-01-2012","isContributorPI":"Non","contributorName":"Babak KHOSHNOOD","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.u953.idf.inserm.fr\/page.asp?page"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":"Oui"},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"actif","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Paris et Petite Couronne (92, 93, 94)"},"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"}