{"doc_desc":{"title":"Case-Control Study of Subjects Under 75 Years Old with Prostate Cancer: The Role of Genetic and Environmental Risk Factors","idno":"FRESH-PEF5914-en","producers":[{"name":"Florence MENEGAUX","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5914-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5914"},{"agency":"FReSH","code":"FRESH-PEF5914"}]},"title":"Case-Control Study of Subjects Under 75 Years Old with Prostate Cancer: The Role of Genetic and Environmental Risk Factors","alternate_title":"EPICAP"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Florence;MENEGAUX","PILabo":"INSERM - Institut National de Sant\u00e9 et Recherche \/ INSERM U1018 - CESP - Equipe Exposme et H\u00e9r\u00e9dit\u00e9","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0003-3363-6411","role":"pi id"},{"title":"IdRef","uri":"083449019","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201019083D","role":"labo id"}],"email":"florence.menegaux@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":"Collaboration with the H\u00e9rault Tumour Registry (Brigitte Tr\u00e9tarre), French Urologic Oncology Research Association (ARCOU) (Xavier R\u00e9billard, Fran\u00e7ois Iborra, Rodolphe Thuret and all urologists in the department), the St.-P\u00e8re biological resource centre (CRB) INSERM U775 (Claire Mulot, Pierre Laurent-Puig) and the specialist biology laboratory in the Montpellier Cancer Institute (Pierre-Jean Lamy).","type":"collaboration"}],"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 SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL (ANSES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0471kz689"},{"title":"SIREN","uri":"130012024"}]},{"name":"FONDATION ARC POUR LA RECHERCHE SUR LE CANCER","extlink":[{"title":"SIREN","uri":"752064949"}]},{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]},{"name":"LIGUE NATIONALE CONTRE LE CANCER (LNCC)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rkrv905"},{"title":"SIREN","uri":"775664717"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Florence;MENEGAUX","email":"florence.menegaux@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"}]}]},"study_info":{"keywords":[],"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":"Malignant neoplasms of prostate","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1552457716","title":"CIM-11"}]},{"topic":"Biological determinants: Genetic predisposition","vocab":"health 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  \"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    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Cases: all patients newly diagnosed with prostate cancer in 2012-2013, under 75 years old and residing in H\u00e9rault. Controls: males under 75 years old, residing in H\u00e9rault, who are the same age as the case subjects and free from prostate cancer.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"1,000 cases\/1,000 controls"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"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":"26-04-2013","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2017","isContributorPI":"No","contributorName":"Florence MENEGAUX","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit","Private non-profit","Public (France)","Private non-profit","Private non-profit"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"H\u00e9rault"},"dataTypes":{"clinicalDataDetails":"-----","biologicalDataDetails":"Blood sample (EDTA and dry tubes) or, failing this, a saliva sample.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}