{"doc_desc":{"title":"Entrep\u00f4t de donn\u00e9es de sant\u00e9 clinico-biologiques multidisciplinaire, multicentrique sur le Cancer du Rein","idno":"FRESH-PEF8176-fr","producers":[{"name":"Jean-Christophe BERNHARD","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8176-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8176"},{"agency":"FReSH","code":"FRESH-PEF8176"}]},"title":"Entrep\u00f4t de donn\u00e9es de sant\u00e9 clinico-biologiques multidisciplinaire, multicentrique sur le Cancer du Rein","alternate_title":"UroCCR"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"authoring_entity":[{"name":"Sol\u00e8ne;RICARD","firstname":"Sol\u00e8ne","lastname":"RICARD","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"organisation id"},{"title":"SIREN","uri":"263305823","role":"organisation id"}],"email":"solene.ricard@chu-bordeaux.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","PILabo":"CHU de Bordeaux \/ Service de chirurgie urologique et transplantation - CHU Bordeaux","isContact":true}],"oth_id":[{"name":"Projets ancillaires multicentriques r\u00e9trospectifs et prospectifs et Soutiens scientifiques :- Association Fran\u00e7aise d'Urologie (AFU)- Groupe d'Etude des Tumeurs Uro-G\u00e9nitales (GETUG)- Soci\u00e9t\u00e9 d'Imagerie G\u00e9nito-Urinaire (SIGU)- Club Fran\u00e7ais de Pathologie Urologique- R\u00e9seau Fran\u00e7ais des Registres en Canc\u00e9rologie (FRANCIM)- Association pour la Recherche sur les Tumeurs du Rein (ARTuR)- Universit\u00e9 de Bordeaux- Canc\u00e9rop\u00f4le Grand Sud-Ouest- IBiSA","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":""},{"name":""}]},"distribution_statement":{"contact":[{"name":"Jean-Christophe;BERNHARD","lastname":"BERNHARD","firstname":"Jean-Christophe","type":"contact","email":"jean-christophe.bernhard@chu-bordeaux.fr","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","lastname":"RICARD","firstname":"Sol\u00e8ne","type":"contact","email":"solene.ricard@chu-bordeaux.fr","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":"base de donn\u00e9es clinico-biologiques"},{"keyword":"r\u00e9seau m\u00e9dical et scientifique"},{"keyword":"oncologie m\u00e9dicale"},{"keyword":"traitement ablatif"},{"keyword":"anatomopathologie"},{"keyword":"oncog\u00e9n\u00e9tique"},{"keyword":"prise en charge th\u00e9rapeutique"},{"keyword":"chirurgie"},{"keyword":"Cancer du rein"}],"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":"N\u00e9phrologie","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":"Tumeurs","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif principal est de s\u2019appuyer sur un outil commun multidisciplinaire et f\u00e9d\u00e9rateur (Base de donn\u00e9es UroCCR), pour d\u00e9velopper un r\u00e9seau m\u00e9dico-scientifique national \u00e0 l\u2019activit\u00e9 centr\u00e9e sur la prise en charge th\u00e9rapeutique et la recherche appliqu\u00e9e au cancer du rein. La compl\u00e9mentarit\u00e9 des comp\u00e9tences et culture d\u2019un lien translationnel fort, la collaboration avec les Registres en canc\u00e9rologie, la cr\u00e9ation d\u2019une collection d\u2019\u00e9chantillons biologiques annot\u00e9e multicentrique, permettent de stimuler la r\u00e9alisation de projets de recherche ancillaires au sein du r\u00e9seau UroCCR tout en visant une efficience \u00e9conomique en termes de d\u00e9lais de mise en place.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"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\": \" Patient majeur atteint d'un cancer du rein - Patient ne s'opposant pas au recueil de donn\u00e9es le concernant pour l'\u00e9tude\",\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']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\r\nConsommation de soins\/services de sant\u00e9"}]},"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\":\"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":"20 269 patients (03\/04\/2025)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"La base de donn\u00e9e est anonymis\u00e9e, pour assurer la confidentialit\u00e9 des donn\u00e9es","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"La base de donn\u00e9e est s\u00e9curis\u00e9e par un acc\u00e8s chiffr\u00e9 (protocole https) et un compte utilisateur individuel (identifiant et mot de passe) garantissant la protection des donn\u00e9es propres \u00e0 chaque centre.","conditions":"L'acc\u00e8s aux donn\u00e9es par une \u00e9quipe tierce se fait apr\u00e8s validation du projet pr\u00e9sent\u00e9 en Comit\u00e9 Scientifique.","conf_dec":[{"txt":"La confidentialit\u00e9 des donn\u00e9es recueillies pour la base UroCCR est garantie par : -L'approbation de l'ensemble de l'\u00e9tude par le Comit\u00e9 Consultatif sur le Traitement de l'Information en Mati\u00e8re de Recherche dans le domaine de la Sant\u00e9 et de la Commission Nationale Informatique et Libert\u00e9s. -Le secret professionnel auquel sont soumis tous les membres de l'\u00e9quipe UroCCR (signature d'un engagement de confidentialit\u00e9) ainsi que les centres participants (signature d\u2019une charte de partenariat vis-\u00e0-vis des r\u00e8gles de confidentialit\u00e9). -L'analyse des donn\u00e9es recueillies qui est faite de mani\u00e8re strictement anonyme."}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"25-02-2014","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Le recueil des donn\u00e9es se fait via la base EDS de donn\u00e9es relationnelle accessible de fa\u00e7on s\u00e9curis\u00e9e comportant l\u2019ensemble des variables d\u00e9mographiques, de chirurgie, d'anatomo-pathologie, de radiologie, de traitement ablatif, d'oncog\u00e9n\u00e9tique et d'oncologie m\u00e9dicale (incluant les donn\u00e9es du r\u00e9f\u00e9rentiel de l'INCa).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"58 centres dans le R\u00e9seau UroCCR : 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":"Int\u00e9resse tous les champs diagnostiques et th\u00e9rapeutiques du Cancer du Rein (chirurgie ouverte et mini-invasive, radiologie interventionnelle, proc\u00e9dures associ\u00e9es de prise en charge des localisations m\u00e9tastatiques, th\u00e9rapies cibl\u00e9es).","biologicalDataDetails":"Collection virtuelle d'\u00e9chantillons biologiques : Tissus tumoraux, tissus sains, urines, plasma, s\u00e9rum.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}