{"doc_desc":{"title":"REGISTRE BOURGUIGNON DES CANCERS DIGESTIFS (registre qualifi\u00e9)","idno":"FRESH-PEF217-fr","producers":[{"name":"Anne-Marie BOUVIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF217-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"217"},{"agency":"FReSH","code":"FRESH-PEF217"}]},"title":"REGISTRE BOURGUIGNON DES CANCERS DIGESTIFS (registre qualifi\u00e9)","alternate_title":"RBCD"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Anne-Marie;BOUVIER","PILabo":"CHU; UFR Sant\u00e9 Bourgogne - Franche Comt\u00e9 \/ Centre de Recherche INSERM U1231","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ORCID","uri":"0000-0001-9070-1027","role":"pi id"},{"title":"IdRef","uri":"082085005","role":"pi id"},{"title":"SIREN","uri":"262100076","role":"organisation id"},{"title":"RNSR","uri":"200716508T","role":"labo id"}],"email":"anne-marie.bouvier@u-bourgogne.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0377z4z10","role":"sponsor id"},{"title":"SIREN","uri":"262100076","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE BOURGOGNE EUROPE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00g700j37","role":"sponsor id"},{"title":"SIREN","uri":"938230612","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"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":"Anne-Marie;BOUVIER","email":"anne-marie.bouvier@u-bourgogne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id","title":"ROR"},{"uri":"262100076","role":"organisation id","title":"SIREN"}]},{"name":"Val\u00e9rie;JOOSTE","email":"vjooste@u-bourgogne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0377z4z10","role":"organisation id","title":"ROR"},{"uri":"262100076","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pratiques de soins"},{"keyword":"tendances \u00e9volutives"},{"keyword":"\u00e9pid\u00e9miologie"},{"keyword":"sant\u00e9 publique"},{"keyword":"survie"}],"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":"Gastroent\u00e9rologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Tumeurs malignes d'organes digestifs, autres ou impr\u00e9cis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1425921467","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"- Objectifs du registre en termes sant\u00e9 publique (surveillance, \u00e9valuation) En termes d\u2019observation en sant\u00e9 publique nous participons \u00e0 la surveillance sanitaire et \u00e0 la planification des soins par la production d\u2019indicateurs (incidence, pr\u00e9valence, survie et tendances temporelles) au niveau local et au niveau national dans le cadre du r\u00e9seau Francim en partenariat avec Sant\u00e9 Publique France, l\u2019Institut du Cancer et les Hospices Civils de Lyon (HCL). Une grande partie de ces objectifs sont d\u00e9finis dans le cadre d'un programme de travail partenarial avec les HCL, l\u2019InVS et l\u2019INCa. La sp\u00e9cialisation du registre permet d\u2019\u00e9valuer les \u00ab pratiques de soins \u00bb, quel que soit le secteur de soins, et d\u2019\u00e9valuer l\u2019\u00e9volution des indicateurs de qualit\u00e9 des soins. Cette activit\u00e9 est men\u00e9e \u00e0 l\u2019\u00e9chelon local, national par interaction avec nos partenaires (en particulier le registre digestif du Calvados) et \u00e0 l\u2019\u00e9chelon international en participant aux projets collaboratifs. - Objectifs du registre en termes de recherche Les objectifs de recherche du registre sont centr\u00e9s sur la \u00ab prise en charge \u00bb des cancers digestifs, avec un int\u00e9r\u00eat particulier pour le cancer colorectal du fait de sa fr\u00e9quence. Ils concernent en particulier : La d\u00e9termination des groupes \u00e0 risque et \u00e9pid\u00e9miologie des l\u00e9sions pr\u00e9canc\u00e9reuses L\u2019\u00e9tude des in\u00e9galit\u00e9s de traitement des cancers digestifs Optimisation des strat\u00e9gies de surveillance Le d\u00e9veloppement et application de nouvelles approches m\u00e9thodologiques d\u2019analyse de la gu\u00e9rison et de la survie L\u2019\u00e9valuation du d\u00e9pistage organis\u00e9 du cancer colorectal","abstract":"","coll_dates":[{"start":"1976-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Bourgogne Franche-Comt\u00e9']","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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Les tumeurs malignes et invasives lors de la premi\u00e8re mise en \u00e9vidence de la localisation primitive et les tumeurs malignes non infiltrantes, dites in situ ou intra \u00e9pith\u00e9liales, lorsque aucune tumeur invasive de m\u00eame type histologique et de m\u00eame localisation n\u2019est pr\u00e9c\u00e9demment apparue chez le m\u00eame sujet.  Les calculs d\u2019incidence ne tiennent compte que des tumeurs malignes invasives.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es comportementales']","quality_statement":{"standards":[{"name":"['nomenclatures standardis\u00e9es internationales communes aux registres europ\u00e9ens']","committee":"","governance":""}],"other_quality_statement":"['charte de qualit\u00e9 commune FRANCIM. evaluation devant commission ad hoc tous les 4 ans']"}},"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":""}},"coll_mode":["{\"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":[],"target_sample_size":">= 20000 individus","response_rate":"plus de 50 000 cas"},"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 pour les partenaires acad\u00e9miques apr\u00e8s validations d'un projet scientifique et consensus r\u00e9glementaire au regard des nouvelles r\u00e8glementations europ\u00e9ennes de protection des individus","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":"27-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Anne-Marie BOUVIER","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE DIJON","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-RBCD"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"actif: le registre va lui-m\u00eame \u00e0 la recherche des informations aupr\u00e8s des diff\u00e9rentes sources.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"r\u00e9gion Bourgogne: d\u00e9partements de la c\u00f4te d'Or et de la Sa\u00f4ne et Loire"},"dataTypes":{"clinicalDataDetails":"les donn\u00e9es cliniques concernant le patient au moment du diagnostic de sa maladie et au cours de son suivi","biologicalDataDetails":"coordination m\u00e9thodologique d'une tumoroth\u00e8que recueillant les pr\u00e9l\u00e8vements tissulaires d'ad\u00e9nocarcinomes colorectaux r\u00e9s\u00e9qu\u00e9s du d\u00e9partement de la C\u00f4te d'Or","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}