{"doc_desc":{"title":"Registre des h\u00e9mopathies malignes de la Gironde (Registre qualifi\u00e9 2013 - 2016)","idno":"FRESH-PEF226-fr","producers":[{"name":"Alain MONNEREAU","affiliation":"INSTITUT BERGONIE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF226-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"226"},{"agency":"FReSH","code":"FRESH-PEF226"}]},"title":"Registre des h\u00e9mopathies malignes de la Gironde (Registre qualifi\u00e9 2013 - 2016)","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Alain;MONNEREAU","PILabo":"Institut Bergoni\u00e9, Centre R\u00e9gional de Lutte Contre le Cancer de Bordeaux et du","affiliationName":"INSTITUT BERGONIE","extlink":[{"title":"ORCID","uri":"0000-0002-5056-1397","role":"pi id"},{"title":"IdRef","uri":"13067706X","role":"pi id"},{"title":"SIREN","uri":"781831714","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"monnereau@bergonie.org","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT BERGONIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02yw1f353","role":"sponsor id"},{"title":"SIREN","uri":"781831714","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT BERGONIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02yw1f353"},{"title":"SIREN","uri":"781831714"}]},{"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":"Alain;MONNEREAU","email":"monnereau@bergonie.org","type":"contact","affiliationName":"INSTITUT BERGONIE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02yw1f353","role":"organisation id","title":"ROR"},{"uri":"781831714","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"dispositif"},{"keyword":"surveillance sanitaire"}],"topics":[{"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":"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 h\u00e9matopo\u00ef\u00e9tiques malignes, sans autre pr\u00e9cision","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1510618119","title":"CIM-11"}]}],"purpose":"Un des objectifs essentiels du registre est d\u2019am\u00e9liorer le dispositif de surveillance sanitaire des h\u00e9mopathies malignes localement et en France : - par l\u2019analyse des donn\u00e9es d\u2019incidence des diff\u00e9rents types d\u2019h\u00e9mopathies malignes : description de la fr\u00e9quence et de la distribution de chaque entit\u00e9 selon le temps, l\u2019espace et les caract\u00e9ristiques de la population, - par la production de taux de r\u00e9f\u00e9rence fiables pour aider l\u2019investigation des clusters, - par la veille sur les effets secondaires des th\u00e9rapeutiques (ex : leuc\u00e9mies secondaires), - par la participation active \u00e0 l\u2019am\u00e9lioration du syst\u00e8me de surveillance (expertise dans l\u2019enregistrement des h\u00e9mopathies malignes ; programme d\u2019am\u00e9lioration de l\u2019enregistrement des cas en France). L\u2019\u00e9pid\u00e9miologie clinique ou \u00e9valuative en population g\u00e9n\u00e9rale est \u00e9galement un des objectifs principaux du registre : - \u00e9valuer les pratiques, les trajectoires et les fili\u00e8res de soins, leur \u00e9volution au cours du temps, l\u2019impact des r\u00e9f\u00e9rentiels de pratique sur la qualit\u00e9 des soins et la survie, - estimer la survie relative et la pr\u00e9valence des h\u00e9mopathies malignes \u00e0 des fins de comparaison avec d\u2019autres r\u00e9gions ou pays et pour estimer les besoins en ressources pour le diagnostic et les soins (chimioth\u00e9rapie, greffe, radioth\u00e9rapie), en particulier pour la population \u00e2g\u00e9e (forte proportion des cas), - \u00e9valuer la diffusion et l\u2019impact de la recherche clinique en mesurant l\u2019applicabilit\u00e9 des essais th\u00e9rapeutiques et l\u2019impact des progr\u00e8s th\u00e9rapeutiques sur la quantit\u00e9 \/ qualit\u00e9 de vie des patients, Le registre a d\u2019embl\u00e9e \u00e9t\u00e9 con\u00e7u comme un outil permettant de participer voire d\u2019initier un programme de recherche \u00e9pid\u00e9miologique sur les h\u00e9mopathies malignes dans plusieurs domaines. L\u2019\u00e9pid\u00e9miologie descriptive, \u00e9tudes \u00e9cologiques ou cas\/t\u00e9moins, \u00e9tudes sur l\u2019acc\u00e8s aux soins et des \u00e9tudes pronostiques en population, recherche pluridisciplinaires avec les Sciences Humaines et Sociales).","abstract":"","coll_dates":[{"start":"2002-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Le registre inclut, depuis le 1er janvier 2002, tout cas incident d\u2019h\u00e9mopathie maligne (leuc\u00e9mie, lymphome, my\u00e9lome, syndrome my\u00e9lodysplasique, syndrome my\u00e9loprolif\u00e9ratif) port\u00e9 chez un sujet r\u00e9sidant r\u00e9guli\u00e8rement en Gironde au moment de son diagnostic.\",\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','Donn\u00e9es paracliniques (hors biologiques) : Autre']","quality_statement":{"standards":[{"name":"['Classification Internationale des Maladies appliqu\u00e9e \u00e0 l\u2019oncologie (3\u00e8me version)']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nAutres"}]},"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 libre","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2002-2008 : 5000"},"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":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Transmission \u00e0 la base nationale Francim puis \u00e0 l'Institut de Veille Sanitaire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"03-01-2011","lastUpdatedAuto":null,"lastUpdatedManual":"23-01-2015","isContributorPI":"Non","contributorName":"Alain MONNEREAU","contributorAffiliation":"INSTITUT BERGONIE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/18781390"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Recueil actif ou passif (fichier informatique)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Gironde"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Bilan biologique initial (H\u00e9mogramme, My\u00e9logramme, Biopsie ost\u00e9om\u00e9dullaire Immunoph\u00e9notypage, Anomalies cytog\u00e9n\u00e9tiques, Examens biologiques \u00e0 vis\u00e9e pronostique).","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}