{"doc_desc":{"title":"Etude longitudinale sur des patients atteints du cancer de la prostate (CaP)","idno":"FRESH-PEF148-fr","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF148-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"148"},{"agency":"FReSH","code":"FRESH-PEF148"}]},"title":"Etude longitudinale sur des patients atteints du cancer de la prostate (CaP)","alternate_title":"CAPTURE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Christel;LECLERC-ZWIRN","firstname":"Christel","lastname":"LECLERC-ZWIRN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id"},{"title":"SIREN","uri":"592052146","role":"organisation id"}],"email":"christel.c.leclerc-zwirn@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","PILabo":"Laboratoire GSK","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"sponsor id"},{"title":"SIREN","uri":"592052146","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]}]},"distribution_statement":{"contact":[{"name":"Christel;LECLERC-ZWIRN","lastname":"LECLERC-ZWIRN","firstname":"Christel","type":"contact","email":"christel.c.leclerc-zwirn@gsk.com","affiliationName":"GLAXOSMITHKLINE (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id","title":"ROR"},{"uri":"592052146","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prostate"},{"keyword":"cancer"}],"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":"Andrologie et urologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7341b8bd-fcb0-44c1-9ca9-8752b542ed59"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D033441"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014572"}]}],"purpose":"\u2022 \u00c9valuer l\u2019impact du CaP de risque faible \u00e0 mod\u00e9r\u00e9 sur la qualit\u00e9 de vie et l\u2019anxi\u00e9t\u00e9\/la d\u00e9pression du sujet au moment du diagnostic et au cours de la premi\u00e8re ann\u00e9e de traitement. \u2022 Estimer la consommation de soins et services de sant\u00e9 au cours de la premi\u00e8re ann\u00e9e suivant le diagnostic de CaP de risque faible \u00e0 mod\u00e9r\u00e9. \u2022 D\u00e9crire le profil et la prise en charge m\u00e9dicale des sujets atteints de CaP de risque faible \u00e0 mod\u00e9r\u00e9 dans 5 pays de l\u2019Union europ\u00e9enne (UE) (France, Allemagne, Italie, Espagne et Su\u00e8de).","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}}],"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    \"level_age_clusion_I\": [\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"1.D\u00e9mographie : hommes \u00e2g\u00e9s de 50 \u00e0 75 ans. 2.Caract\u00e9ristiques de la maladie : score de Gleason compris entre 6 et 10ng\\\/ml et stade clinique T1c \u00e0 T2b (selon les crit\u00e8res de D\u2019Amico d\u00e9finissant un risque faible \u00e0 interm\u00e9diaire [D\u2019Amico, 1998]). 3.Consentement \u00e9clair\u00e9 : le sujet est d\u00e9sireux et capable de fournir son consentement \u00e9clair\u00e9 \u00e9crit. 4.Alphab\u00e9tisme : capable de lire et \u00e9crire pour r\u00e9pondre aux questionnaires de l\u2019\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation 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 les professionnels d&#x27;exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"116 (France)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Pour cette \u00e9tude, les donn\u00e9es concernant les sujets sont recueillies en utilisant des cahiers d\u2019observation Cette \u00e9tude utilise 3 questionnaires de QdV et deux autres questionnaires, comme r\u00e9sum\u00e9 ci-dessous :\u2022 Qualit\u00e9 de vie sp\u00e9cifique: QLQ-C30 (cancer) et QLQ-PR25 (cancer de la prostate).\u2022 Qualit\u00e9 de vie g\u00e9n\u00e9rale: EQ-5D.\u2022 Anxi\u00e9t\u00e9\/D\u00e9pression: HADS.\u2022 Indice d\u2019\u00e9valuation de la productivit\u00e9 au travail (WPAI).Il est demand\u00e9 aux sujets de compl\u00e9ter les questionnaires dans l\u2019ordre suivant : QLQ-C30\/QLQ-PR25, EQ-5D, HADS et WPAI. Il est \u00e9galement demand\u00e9 au m\u00e9decin de tenir un registre d\u2019utilisation de ressources li\u00e9es \u00e0 la prostate.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France, Allemagne, Italie, Espagne et Su\u00e8de"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}