{"doc_desc":{"title":"Cohorte de patients atteints d\u2019un cancer du rein m\u00e9tastatique en premi\u00e8re ligne de traitement ayant d\u00e9but\u00e9 un traitement par anti-angiog\u00e9nique","idno":"FRESH-PEF2857-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2857-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2857"},{"agency":"FReSH","code":"FRESH-PEF2857"}]},"title":"Cohorte de patients atteints d\u2019un cancer du rein m\u00e9tastatique en premi\u00e8re ligne de traitement ayant d\u00e9but\u00e9 un traitement par anti-angiog\u00e9nique","alternate_title":"SANTORIN : Surveillance des ANTi-angiOg\u00e9niques en situation d'utilisation en vie R\u00e9elle dans le cancer du reIN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Annie;FOURRIER-REGLAT","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"030331978","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"annie.fourrier-reglat@u-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Nicholas;MOORE","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-1212-2817","role":"pi id"},{"title":"IdRef","uri":"077852877","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"nicholas.moore@u-bordeaux.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Annie;FOURRIER-REGLAT","email":"annie.fourrier-reglat@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Nicholas;MOORE","email":"nicholas.moore@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Cancer du rein m\u00e9tastatique"},{"keyword":"anti-angiog\u00e9niques"},{"keyword":"toxicit\u00e9"},{"keyword":"premi\u00e8re ligne"},{"keyword":"tol\u00e9rance"},{"keyword":"survie"},{"keyword":"conditions d\u2019utilisation"},{"keyword":"th\u00e9rapies cibl\u00e9es"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"cohorte"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"}],"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":"Tumeurs malignes, d\u00e9clar\u00e9es ou suppos\u00e9es primitives, de localisations pr\u00e9cis\u00e9es, \u00e0 l'exception des tissus lympho\u00efde, h\u00e9matopo\u00ef\u00e9tique, du syst\u00e8me nerveux central ou de tissus apparent\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1643222460","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L'objectif principal est d'estimer la survie globale \u00e0 24 mois des patients atteints d\u2019un cancer du rein m\u00e9tastatique, trait\u00e9s dans la vie r\u00e9elle par anti-angiog\u00e9nique en premi\u00e8re ligne et v\u00e9rifier (pour les produits pour lesquels suffisamment de donn\u00e9es auront \u00e9t\u00e9 recueillies) si elle diff\u00e8re ou non de celle rapport\u00e9e dans les essais cliniques pivots ayant contribu\u00e9 aux acceptations d\u2019AMM.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2012-01-01"}],"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 atteint d\u2019un cancer du rein m\u00e9tastatique en premi\u00e8re ligne de traitement ayant d\u00e9but\u00e9 un traitement par anti-angiog\u00e9nique sur la p\u00e9riode d\u2019inclusion (que le traitement soit poursuivi ou non) ;  Patient n\u2019ayant jamais \u00e9t\u00e9 trait\u00e9 auparavant par anti-angiog\u00e9nique, y compris au cours d\u2019un essai clinique ou en Autorisation Temporaire d\u2019Utilisation ;  Patient pouvant \u00eatre suivi pendant 2 ans ;  Patient trait\u00e9 par un anti-angiog\u00e9nique dont la pr\u00e9sence sur le march\u00e9 fran\u00e7ais date de plus de 6 mois ;  Patient ne participant pas \u00e0 un essai th\u00e9rapeutique ;  Patient non confront\u00e9 \u00e0 la barri\u00e8re linguistique (impossibilit\u00e9 de lire la lettre d\u2019information ou de compl\u00e9ter l\u2019auto-questionnaire patient) ;  Patient ne s'opposant pas au recueil des donn\u00e9es le concernant.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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\"}","{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"522 patients identifi\u00e9s, 390 patients inclus - 522 patients identified, of which 390 patients were included"},"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\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La propri\u00e9t\u00e9 des donn\u00e9es de l'\u00e9tude a fait l'objet d'une convention entre l'Universit\u00e9 Bordeaux Segalen et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"30-05-2011","lastUpdatedAuto":null,"lastUpdatedManual":"17-02-2020","isContributorPI":"Non","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/28573786"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"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 cliniques et d\u2019utilisation des anti-angiog\u00e9niques sont recueillies \u00e0 partir de deux sources de donn\u00e9es : les dossiers m\u00e9dicaux des centres responsables du suivi des patients inclus (eCRF compl\u00e9t\u00e9 par un ARC) et des auto-questionnaires patient sur format papier.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"M\u00e9decins hospitaliers prescripteurs d'anti-angiog\u00e9niques en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}