{"doc_desc":{"title":"National Multicentre, Multidisciplinary, Clinical-Biological Database for Kidney Cancer","idno":"FRESH-PEF8176-en","producers":[{"name":"Jean-Christophe BERNHARD","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8176-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8176"},{"agency":"FReSH","code":"FRESH-PEF8176"}]},"title":"National Multicentre, Multidisciplinary, Clinical-Biological Database for Kidney Cancer","alternate_title":"UroCCR"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Sol\u00e8ne;RICARD","PILabo":"CHU de Bordeaux \/ Service de chirurgie urologique et transplantation - CHU Bordeaux","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"263305823","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"solene.ricard@chu-bordeaux.fr","isContact":"Yes"}],"oth_id":[{"name":"Prospective ancillary projects: - Robotic Partial Nephrectomy national study (RoPaN) - Cancer and tArgeted theRapy: survey of Long term Adverse events (CARLA Rein) Partnerships and scientific support: - French Urology Association (AFU) - Urogenital Tumours Study Group (GETUG) - Urogenital Imaging Society (SIGU) - French Urological Pathology Club - French Cancer Registry Network (FRANCIM) - Kidney Tumour Research Association (ARTuR) - University of Bordeaux - Canc\u00e9rop\u00f4le Grand Sud-Ouest - IBiSA","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","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":"","extlink":[]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Jean-Christophe;BERNHARD","email":"jean-christophe.bernhard@chu-bordeaux.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id","title":"ROR"},{"uri":"263305823","role":"organisation id","title":"SIREN"}]},{"name":"Sol\u00e8ne;RICARD","email":"solene.ricard@chu-bordeaux.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id","title":"ROR"},{"uri":"263305823","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"kidney cancer"},{"keyword":"clinical-biological database"},{"keyword":"medical and scientific network"},{"keyword":"medical oncology"},{"keyword":"ablation treatment"},{"keyword":"anatomical pathology"},{"keyword":"oncogenetics"},{"keyword":"therapeutic treatment"},{"keyword":"surgery"}],"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":"Nephrology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Neoplasms","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The main objective is to rely on a common multidisciplinary and unifying tool (UroCCR Database), to develop a national network of medical and scientific activity focused on therapeutic treatment and applied research for kidney cancer. The complementarity of skills and culture of a strong translational connection, collaboration with cancer registries and the creation of a collection of multicentre, annotated biological samples allow ancillary research projects to be carried out as part of the UroCCR network, aimed at economic and lead time efficiency.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"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\": \"Adult patient with kidney cancer - Patient not objecting to the collection of data for the study\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"20 269 patients (2025\/04\/03)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"The database is anonymous to ensure data confidentiality","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"The database is secured by an encrypted connection (https) and an individual user account (username and password), ensuring data protection for each centre.","conditions":"Approval of the entire study by the Advisory Committee on Research Information Processing in the Health Field and the National Commission for Data Protection and Liberties (CNIL).","conf_dec":[{"txt":"The confidentiality of data collected for UroCCR base is assured by: - Approval of the entire study by the Advisory Committee on Research Information Processing in the Health Field and the National Commission for Data Protection and Liberties (CNIL). - Professional confidentiality to which all members of UroCCR are subjected to (signing a confidentiality agreement), as well as the participating centres (signing a partnership charter on confidentiality regulations). - Strictly anonymous analysis of collected data."}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"25-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":"No","contributorName":"Jean-Christophe BERNHARD","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industry","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"Data collection is through a relational database with secure access that includes all variables regarding demographics, surgery, anatomic pathology, radiology, ablative treatment, oncogenetics and medical oncology (including INCa repository database).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"58 centers in the UroCCR network : CHU de Bordeaux, CHU Kremlin-Bic\u00eatre, CHU Toulouse, CHU Lyon, CHU Rennes, HEGP, CHU Angers, CHU Strasbourg, CHU Grenoble, CH St-Joseph, CHU Henri Mondor, H\u00f4pital La Piti\u00e9 Salp\u00eatri\u00e8re, CHU Rouen, CHU Lille, CHU Caen, CHU Reims, CHU Tours, H\u00f4pital Bichat, CHU Poitiers, IPC Marseille, APH Marseille, CHU Nice, H\u00f4pital Tenon, CHU Clermont-Ferrand, M\u00e9dip\u00f4le Cabestany, CH Mont de Marsan, H\u00f4pital Priv\u00e9 Claude Galien, Clinique la Croix du Sud, H\u00f4pital Priv\u00e9 Francheville, CH de Libourne, P\u00f4le Sud Sant\u00e9-Le-Mans, Clinique Pasteur, Clinique Sant\u00e9 Atlantique, CHU N\u00eemes, H\u00f4pital Priv\u00e9 des C\u00f4tes d'Amor, CHU de Nantes, H\u00f4pital Priv\u00e9 La Louvi\u00e8re Lille, Clinique Nantes Atlantis, Clinique du Pont de Chaume, CHU Dijon, ICANS, CH de Kourou (Guyane), H\u00f4pital Foch, CHU Cochin-Port Royal, CH de Fontainebleau, Nouvelle Clinique Bordeaux Tondu, Clinique Belledonne, Clinique Saint-Antoine, CHU de St ETIENNE, H\u00f4pital Universitaire de Bruxelles, CH SUD FRANCILIEN, Institut Mutualiste Montsouris, CHRU de Nancy, CHU de Limoges, CH d\u2019Annecy, CH D\u00e9partement de Vend\u00e9e, CHU d\u2019Orl\u00e9ans, CHU Bellepierre Saint-Denis (La R\u00e9union)"},"dataTypes":{"clinicalDataDetails":"Concerns all kidney cancer diagnostic and therapeutic fields (open and mini-invasive surgery, interventional radiology, procedures associated with treating metastases, targeted therapies).","biologicalDataDetails":"Virtual collection of biological samples: Abnormal tissue, healthy tissue, urine, plasma and serum.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}