{"doc_desc":{"title":"Registre National des H\u00e9mopathies malignes de l'Enfant (Avis CER 2015-2020)","idno":"FRESH-PEF61-fr","producers":[{"name":"Jacqueline CLAVEL","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF61-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"61"},{"agency":"FReSH","code":"FRESH-PEF61"}]},"title":"Registre National des H\u00e9mopathies malignes de l'Enfant (Avis CER 2015-2020)","alternate_title":"RNHE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Jacqueline;CLAVEL","PILabo":"Institut national de la sant\u00e9 et de la recherche m\u00e9dicale \/ UMRS-1153 Equipe 7, INSERM, Universit\u00e9 Paris Descartes","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-3616-7676","role":"pi id"},{"title":"IdRef","uri":"073987484","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jacqueline.clavel@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"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":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":"Jacqueline;CLAVEL","email":"jacqueline.clavel@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":"expositions particuli\u00e8res"},{"keyword":"expositions environnementales"},{"keyword":"fili\u00e8res de soin"},{"keyword":"incidence"},{"keyword":"leuc\u00e9mie"},{"keyword":"surveillance"},{"keyword":"survie"},{"keyword":"population g\u00e9n\u00e9rale"},{"keyword":"scanner"},{"keyword":"HIV"},{"keyword":"sympt\u00f4mes"},{"keyword":"traitement"},{"keyword":"lymphome"},{"keyword":"ant\u00e9c\u00e9dents"},{"keyword":"cytog\u00e9n\u00e9tique"},{"keyword":"rechute"}],"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":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"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":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"1_Surveillance - \u00c9tablir des taux d'incidence fiables pour les diff\u00e9rents types de leuc\u00e9mies et de lymphomes. et \u00e9tudier leurs variations et leurs d\u00e9terminants socio-d\u00e9mographiques - Assurer la surveillance continue de l'incidence et d\u00e9tecter une augmentation \u00e9ventuelle de l'incidence nationale ou localis\u00e9e. - Fournir l'estimation de la survie en population g\u00e9n\u00e9rale des diff\u00e9rents types de leuc\u00e9mies et lymphomes. - Contribuer au suivi du risque de cancers p\u00e9diatriques dans des populations soumises \u00e0 des expositions particuli\u00e8res (enfants ayant eu un scanner, enfant de m\u00e8re HIV et trait\u00e9s en p\u00e9riode p\u00e9rinatale, expositions aux pesticides, expositions aux rayons ultraviolets... ). 2- Recherche Contribuer aux travaux de recherche sur les facteurs de risque des cancers de l'enfant d\u00e9velopp\u00e9s par l'\u00e9quipe \u00c9pid\u00e9miologie des cancers de l'enfant et de l'adolescent du CRESS, INSERM U1153. Contribuer aux travaux de recherche d'autres \u00e9quipes et disciplines (voir Plateforme d'observation des cancers de l'enfant, CCOP) 3- Suivi long terme Contribuer au suivi des s\u00e9quelles et effets secondaires des traitements des personnes ayant eu un cancer dans leur enfance depuis l'ann\u00e9e 200 (voir Plateforme d'observation des cancers de l'enfant, CCOP)","abstract":"","coll_dates":[{"start":"1990-01-01"}],"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\": \"Patients \u00e2g\u00e9s de moins de 18 ans atteints d'une h\u00e9mopathie maligne ou borderline, et qui r\u00e9sident en France m\u00e9tropolitaine ou dans un De\u0301partement d\u2019Outre-Mer au moment du diagnostic : Guadeloupe, Martinique, Guyane, La R\u00e9union.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"['CIM-O-3 \/ ICCC-3']","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\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":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[10000-20000[ individus","response_rate":"19820"},"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":"Contacter le responsable 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Des sources suppl\u00e9mentaires sont utilis\u00e9es pour l'identification de nouveaux cas: PMSI, Caisse d'assurance maladie,, C\u00e9piDc","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"Territoire m\u00e9tropolitain + DOM"},"dataTypes":{"clinicalDataDetails":"Mode de d\u00e9couverte, date des premiers sympt\u00f4mes, nature des sympt\u00f4mes, ant\u00e9c\u00e9dents m\u00e9dicaux personnels, ant\u00e9c\u00e9dents m\u00e9dicaux familiaux","biologicalDataDetails":"Cytologie, histologie, immunoph\u00e9notypage, cytog\u00e9n\u00e9tique conventionnelle et mol\u00e9culaire, biologie mol\u00e9culaire, imagerie, stade","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}