{"doc_desc":{"title":"Case-Control Study on the Relationship Between Environmental, Domestic and Occupational Exposure during Early Life, and the Risk of Germ Cell Testicular Cancer in Adulthood","idno":"FRESH-PEF33513-en","producers":[{"name":"B\u00e9atrice FERVERS","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF33513-en","IDno":{"metadata_no":[{"agency":"PEF","code":"33513"},{"agency":"FReSH","code":"FRESH-PEF33513"}]},"title":"Case-Control Study on the Relationship Between Environmental, Domestic and Occupational Exposure during Early Life, and the Risk of Germ Cell Testicular Cancer in Adulthood","alternate_title":"TESTIS"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Olivia;PEROL","PILabo":"L\u00e9on Centre \/ Cancer and Environment Unit","affiliationName":"CENTRE LEON BERARD","extlink":[{"title":"ORCID","uri":"0000-0002-7543-7050","role":"pi id"},{"title":"IdRef","uri":"268540977","role":"pi id"},{"title":"SIREN","uri":"779924133","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"olivia.perol@lyon.unicancer.fr","isContact":"Yes"},{"type":"investigator","name":"B\u00e9atrice;FERVERS","PILabo":"L\u00e9on B\u00e9rard Centre; Claude Bernard University, Lyon \/ Unit\u00e9 \u00ab Cancer et Environnement \u00bb","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","extlink":[{"title":"ORCID","uri":"0000-0003-3498-6499","role":"pi id"},{"title":"IdRef","uri":"060410442","role":"pi id"},{"title":"SIREN","uri":"196917744","role":"organisation id"},{"title":"RNSR","uri":"201019057A","role":"labo id"}],"email":"beatrice.fervers@lyon.unicancer.fr","isContact":"Yes"},{"type":"investigator","name":"R\u00e9mi;BERANGER","PILabo":"L\u00e9on B\u00e9rard Centre; Claude Bernard University Lyon 1; International Research Centre \/ Cancer and Environment Unit","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","extlink":[{"title":"ORCID","uri":"0000-0002-6608-8020","role":"pi id"},{"title":"IdRef","uri":"128482915","role":"pi id"},{"title":"SIREN","uri":"196917744","role":"organisation id"},{"title":"RNSR","uri":"201019057A","role":"labo id"}],"email":"remi.beranger@lyon.unicancer.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE LEON BERARD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"sponsor id"},{"title":"SIREN","uri":"779924133","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Olivia;PEROL","email":"olivia.perol@lyon.unicancer.fr","type":"contact","affiliationName":"CENTRE LEON BERARD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id","title":"ROR"},{"uri":"779924133","role":"organisation id","title":"SIREN"}]},{"name":"B\u00e9atrice;FERVERS","email":"beatrice.fervers@lyon.unicancer.fr","type":"contact","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]},{"name":"R\u00e9mi;BERANGER","email":"remi.beranger@lyon.unicancer.fr","type":"contact","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"multiple exposure"},{"keyword":"endocrine disruptors"},{"keyword":"environment"},{"keyword":"pesticides"},{"keyword":"risk factors"}],"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":"Environmental determinants: Climate","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"Main aim: To study the relationship between various exposures, especially to pesticides, during critically sensitive periods in testicular development (pre-conception, intrauterine and early childhood) and the risk of developing testicular cancer in adulthood. Environmental, occupational and domestic exposure will be taken into account in this assessment. Secondary objectives: To investigate the hypothesis of a dual impact (early life and adulthood) by studying the relationship between various exposures (occupational, environmental and domestic) until adulthood and the risk of developing testicular cancer. To study genetic polymorphisms that may be potentially related to TGCT in the literature, as well as the interactions between these polymorphisms and environmental risk factors, including polymorphisms linked to the metabolic pathways of organochlorine pesticides.","abstract":"","coll_dates":[{"start":"2015-01-01"}],"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    \"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    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion criteria:  Case subjects and controls must meet the following criteria to be included: \u2013 Males aged between 18 and 44  \u2013 Born in metropolitan France  \u2013 Can understand, read and write French  \u2013 No psychiatric illness or severe cognitive disorder  \u2013 Volunteered for the study and signed an informed consent \u2013 Member of a social security scheme.   \",\n    \"clusion_E\": \"\u2013 Males under temporary guardianship\u2013 History of TGCT or cryptorchidism (only for controls).\"\n}","data_kind":"['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"}]},"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":"[1000-10000[ individuals","response_rate":"1,500 subjects \u2013 500 cases \u2013 1,000 controls"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Case-control study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","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":"06-03-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2016","isContributorPI":"No","contributorName":"B\u00e9atrice FERVERS","contributorAffiliation":"UNIVERSITE CLAUDE BERNARD LYON 1","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Blind telephone interview conducted by a professional investigator where subject case or control are unknown.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood 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"}