{"doc_desc":{"title":"A COhort to study BLAdder CancEr","idno":"FRESH-PEF3096-en","producers":[{"name":"Maryam KARIMI","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3096-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3096"},{"agency":"FReSH","code":"FRESH-PEF3096"}]},"title":"A COhort to study BLAdder CancEr","alternate_title":"COBLAnCE"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"Bladder cancer"},{"keyword":"urology"},{"keyword":"cancer research"},{"keyword":"cohort"}],"topics":[{"topic":"Oncology","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":"Diseases of the genitourinary system","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/30659757","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"1) To test the association between constitutional DNA polymorphism, environmental parameters, molecular subtype and clinical data. The inclusion of features of both the tumour and the host will facilitate the discovery of tumourigenesis mechanisms, drugable targets and diagnostic and prognostic biomarkers. 2) To provide insight into the tumour progression knowledge and to help to identify biomarkers by the sequential sampling of recurrent tumors, plasma or urine from individual patients during follow_up. 3) To validate and extend our prior results regarding the molecular subtyping of bladder cancer on a large series of tumors collected prospectively. 4) To facilitate the transfer of study results into clinical practice thanks to the size and bladder cancer representativeness of the cohort. 5) To describe treatment patterns and to assess the direct and indirect costs of bladder cancer. The cost variability will be analyzed to identify the determinants of cost. This evaluation will pave the way for cost-benefit analyses of new biomarkers developed by the consortium. 6) To structure, at the national level, an interdisciplinary bladder cancer network including epidempiologists, bioinformaticians, health economists, molecular biologists, occupational physicians, pathologists and urologists, for coordinated and synergistic research actions and to make a significant contribution to a European multinational cohort and support international studies in genomics, in particular.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion as soon as possible after diagnosis of bladder cancer in the 17 participating hospitals\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"2000 patients"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"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":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"10-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Clinical data on the tumour present on inclusion will be obtained from the review of clinical charts by trained monitors. The clinical and pathologic data will include all EAU factors used to predict recurrence and progression (tumour size, multiplicity, stage, grade, associated CIS). All patients will undergo identical interviews, during which they will complete a lifestyle questionnaire (LQ) and quality of life questionnaire (QOL). The lifestyle questionnaire is structured and will be used to collect the following information: demographic details (age\/sex\/education\/place of residence\/social class), complete smoking history, history of drinking habits (water, coffee, tea, alcohol, etc), occupational history and physical activity, and personal medical history and familial history of cancer.Health care resources use and quality of life data will be collected for each patient at baseline and every year during follow-up. Healthcare resource use will be collected both from the medical records in the participating centres and interviewing the patients by telephone. Each patient should give its consent to this data collection including access to national health insurance claims data. The economic questionnaire will be structured according the course of the disease (diagnosis, initial treatment, follow-up, recurrences, and progression including metastatic disease). All medical resources (inpatient - surgery, chemotherapy, etc\u2026- , and, outpatient services and visits) related to bladder cancer will be collected for each patient and during the whole study period. Sick leaves will be collected on a yearly basis until the end of follow-up (e.g. 6 years after inclusion). Unit cost information will be gathered from official sources (mainly national health insurance) to cost each type of resources and compute direct and indirect costs. A special attention will be paid to innovative drugs and technologies including biomarkers research. All this information will be collected on specific structured logsheets.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"DISEASE MANAGEMENT > Disease presentation: presence of symptoms (hematuria, pollakuria, dysuria, urgency, hydronephrosis), alteration of health status > Procedures before diagnostic resection: urinary cytology, urine culture, abdominal ultrasound, urinary tract fibroscopies, imaging (scanner, MRI) > Diagnosis through transurethral resection of the bladder: Hervix or Narrow-Band-Imaging fluorescence, number and location of resected tumors, size and aspect of the largest tumor > Treatment: for NMIBC: intravesical instillations and cystectomy; for MIBC: chemotherapy, radiotherapy, for both NMIBC and MIBC: lymphadenectomy, urethrectomy, nephro-urethrectomy, urinary diversion, blood transfusion, any hospitalization and complications > Outcomes: locoregional and distant recurrences (dates, sites, pathology, treatments, etc.) and death (date and place). PATHOLOGY > Histological type and subtype, prognostic factors, pathological review for all cases at initial diagnosis and in case of recurrence. quality of life > Generic measures (EuroQol EQ-5D-3L","biologicalDataDetails":"DNA, RNA, plasma, protein extracts from blood, tumors and\/or urine","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}