{"doc_desc":{"title":"Cohorte de patients atteints d'un cancer de la vessie","idno":"FRESH-PEF3096-fr","producers":[{"name":"Maryam KARIMI","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3096-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3096"},{"agency":"FReSH","code":"FRESH-PEF3096"}]},"title":"Cohorte de patients atteints d'un cancer de la vessie","alternate_title":"COBLAnCE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Maryam;KARIMI","PILabo":"Inserm \/ Inserm U1018 - Equipe Oncostat","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-3301-8795","role":"pi id"},{"title":"IdRef","uri":"193874318","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"maryam.karimi@gustaveroussy.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"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]}]},"distribution_statement":{"contact":[{"name":"Karine;GROUSSARD","email":"karine.groussard@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"}]},{"name":"Maryam;KARIMI","email":"maryam.karimi@gustaveroussy.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":"cancer de la vessie"},{"keyword":"\u00e9conomie de la sant\u00e9"},{"keyword":"qualit\u00e9 de la vie"},{"keyword":"biobanques"},{"keyword":"environnement"},{"keyword":"g\u00e9n\u00e9tique"},{"keyword":"pronostic"},{"keyword":"biologie mol\u00e9culaire"}],"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":"Maladies de l'appareil g\u00e9nito-urinaire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/30659757","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"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 socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"L'es principaux objectifs de la cohorte COBLAnCE sont : 1) de tester la relation entre les polymorphismes de l'ADN constitutionnel, les param\u00e8tres environnementaux, les sous-types mol\u00e9culaires tumoraux et l'\u00e9volution clinique de la maladie 2) d'am\u00e9liorer le sous-typage mol\u00e9culaire des cancers de la vessie en int\u00e9grant des donn\u00e9es -omics 3) d'am\u00e9liorer la connaissance sur la progression des tumeurs et aider \u00e0 l'identification de biomarqueurs 4) de d\u00e9crire les modalit\u00e9s de prise en charge th\u00e9rapeutique et \u00e9valuer la qualit\u00e9 de vie des patients et les co\u00fbts attribuables au cancer de la vessie.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2024-01-01"}],"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\": \"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\": \"Patients nouvellement diagnostiqu\u00e9s pour un cancer de la vessie dans 14 services services d'urologie r\u00e9partis sur l'ensemble du territoire (h\u00f4pitaux publics et cliniques priv\u00e9es).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Le centre de m\u00e9thodologie est l\\'unit\u00e9 INSERM U1018. Le logiciel utilis\u00e9 pour la gestion de la base de donn\u00e9es est MACRO.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\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":"[1000-10000[ individus","response_rate":"1800"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"Charte d'utilisation des donn\u00e9es en cours de r\u00e9daction avec le service des affaires juridiques de l'INSERM et Inserm-Transfert.","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":"10-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Maryam KARIMI","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/epidemiologie-france.aviesan.fr\/Benhamou S, Bonastre J, Groussard K, Radvanyi F, Allory Y, Lebret T. A prospective multicenter study on bladder cancer: the COBLAnCE cohort. BMC Cancer. 2016;16(1):837."}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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":"Les donn\u00e9es \u00e9pid\u00e9miologiques et de qualit\u00e9 de vie sont recueillies \u00e0 l'inclusion lors d'un interrogatoire en face \u00e0 face. Les donn\u00e9es cliniques sont recueillies \u00e0 partir des dossiers m\u00e9dicaux \u00e0 l'inclusion et durant le suivi. Un auto-questionnaire sur la qualit\u00e9 de vie est envoy\u00e9 aux patients au cours du suivi.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Oui"},"geographicalCoverage":{"geoDetail":"14 centres d'urologie r\u00e9partis en France m\u00e9tropolitaine:"},"dataTypes":{"clinicalDataDetails":"GESTION DE LA MALADIE : Pr\u00e9sentation de la maladie (sympt\u00f4mes (h\u00e9maturie, polyurie, dysurie, urgence, hydron\u00e9phrose), alt\u00e9ration de l'\u00e9tat de sant\u00e9), Proc\u00e9dure avant la r\u00e9section :Cytologie urinaire, \u00e9chographie abdominale, fibroscopie des voies urinaires, imagerie (scanner, IRM). Diagnostic par r\u00e9section transur\u00e9trale de la vessie: Col de l'ut\u00e9rus ou de la fluorescence en bande \u00e9troite \u00e0 l'imagerie, le nombre et l'emplacement de la tumeur r\u00e9s\u00e9qu\u00e9e, la taille et l'aspect de la plus grande tumeur. TRAITEMENT : Traitement: pour TVNIM: instillations intrav\u00e9sicales et cystectomie. Traitement pour TVIM: chimioth\u00e9rapie, radioth\u00e9rapie. Traitement \u00e0 la fois pour TVNIM et TVIM: curage, ur\u00e9trectomie, n\u00e9phro-ur\u00e9trectomie, d\u00e9rivation urinaire, transfusion sanguine, toute hospitalisation et les complications. R\u00e9cidives locor\u00e9gionales et lointaines (dates, lieux, pathologie, traitements, etc.) et la mort (date et lieu). Pathologie (type histologique et sous-type, facteurs pronostiques, l'examen pathologique dans tous les cas au moment du diagnostic initial et en cas de r\u00e9cidive). Qualit\u00e9 de vie (EuroQol EQ-5D-3L","biologicalDataDetails":"Examens de laboratoire (cr\u00e9atine, ur\u00e9e, etc).","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}