{"doc_desc":{"title":"Etude cas-t\u00e9moins visant \u00e0 \u00e9tudier l\u2019association entre diff\u00e9rentes expositions environnementales, domestiques et professionnelles pendant les p\u00e9riodes ant\u00e9natale et pr\u00e9coce, et le risque de tumeur germinale du testicule \u00e0 l\u2019\u00e2ge adulte","idno":"FRESH-PEF33513-fr","producers":[{"name":"B\u00e9atrice FERVERS","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF33513-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"33513"},{"agency":"FReSH","code":"FRESH-PEF33513"}]},"title":"Etude cas-t\u00e9moins visant \u00e0 \u00e9tudier l\u2019association entre diff\u00e9rentes expositions environnementales, domestiques et professionnelles pendant les p\u00e9riodes ant\u00e9natale et pr\u00e9coce, et le risque de tumeur germinale du testicule \u00e0 l\u2019\u00e2ge adulte","alternate_title":"TESTIS"},"study_authorization":{"agency":[{"name":"ANSM"},{"name":"CPP"}]},"authoring_entity":[{"name":"Olivia;PEROL","firstname":"Olivia","lastname":"PEROL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01cmnjq37","role":"organisation id"},{"title":"SIREN","uri":"779924133","role":"organisation id"}],"email":"olivia.perol@lyon.unicancer.fr","affiliationName":"CENTRE LEON BERARD","PILabo":"L\u00e9on Centre \/ Cancer and Environment Unit","isContact":true},{"name":"B\u00e9atrice;FERVERS","firstname":"B\u00e9atrice","lastname":"FERVERS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"SIREN","uri":"196917744","role":"organisation id"}],"email":"beatrice.fervers@lyon.unicancer.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","PILabo":"L\u00e9on B\u00e9rard Centre; Claude Bernard University, Lyon \/ Unit\u00e9 \u00ab Cancer et Environnement \u00bb","isContact":true},{"name":"R\u00e9mi;BERANGER","firstname":"R\u00e9mi","lastname":"BERANGER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"SIREN","uri":"196917744","role":"organisation id"}],"email":"remi.beranger@lyon.unicancer.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","PILabo":"L\u00e9on B\u00e9rard Centre; Claude Bernard University Lyon 1; International Research Centre \/ Cancer and Environment Unit","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","lastname":"PEROL","firstname":"Olivia","type":"contact","email":"olivia.perol@lyon.unicancer.fr","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","lastname":"FERVERS","firstname":"B\u00e9atrice","type":"contact","email":"beatrice.fervers@lyon.unicancer.fr","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","lastname":"BERANGER","firstname":"R\u00e9mi","type":"contact","email":"remi.beranger@lyon.unicancer.fr","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":"Environnement"},{"keyword":"multi-expositions"},{"keyword":"perturbateurs endocriniens"},{"keyword":"pesticides"},{"keyword":"facteur de risque"}],"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":"D\u00e9terminants environnementaux : Climat","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"Objectif principal : Etudier l\u2019association entre diff\u00e9rentes expositions et notamment aux pesticides pendant les p\u00e9riodes de sensibilit\u00e9 critique du d\u00e9veloppement du testicule (pr\u00e9-conceptionnelle, intra-ut\u00e9rine, et jeune enfance) et le risque de d\u00e9velopper un cancer du testicule \u00e0 l\u2019\u00e2ge adulte. Les expositions environnementales, professionnelles et domestiques seront prises en compte dans cette \u00e9valuation. Objectifs secondaires : \u00b7 Explorer l\u2019hypoth\u00e8se d\u2019un double impact (pr\u00e9natal et adulte) en \u00e9tudiant l\u2019association entre diff\u00e9rentes expositions (professionnelles, environnementales et domestiques) jusqu\u2019\u00e0 l\u2019\u00e2ge adulte et le risque de d\u00e9velopper un cancer du testicule. \u00b7 Etudier les polymorphismes g\u00e9n\u00e9tiques identifi\u00e9s comme potentiellement associ\u00e9s au TGCT dans la litt\u00e9rature, puis les interactions entre ces polymorphismes et les facteurs de risque environnementaux retrouv\u00e9s ainsi que les polymorphismes en lien avec les voies de m\u00e9tabolisation des organochlor\u00e9s.","abstract":"","coll_dates":[{"start":"2015-01-01"}],"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    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion Pour \u00eatre inclus dans l\u2019\u00e9tude, les cas et les t\u00e9moins devront remplir tous les crit\u00e8res suivants : \u00b7 Homme \u00e2g\u00e9 de 18 \u00e0 44 ans \u00b7 N\u00e9 en France m\u00e9tropolitaine \u00b7 Capable de comprendre, lire et \u00e9crire le fran\u00e7ais \u00b7 Absence de pathologie psychiatrique ou de trouble cognitif s\u00e9v\u00e8re \u00b7 Volontaire pour participer \u00e0 l\u2019\u00e9tude et ayant dat\u00e9 et sign\u00e9 un consentement \u00e9clair\u00e9 \u00b7 Affili\u00e9 \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale  \",\n    \"clusion_E\": \"\u00b7 Homme plac\u00e9 sous curatelle \u00b7 Ant\u00e9c\u00e9dent de TGCT ou de cryptorchidie (uniquement pour les t\u00e9moins)\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","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"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1500 sujets- 500 cas\/cases - 1000 t\u00e9moins\/controls"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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":"Contacter le responsable scientifique","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":"06-03-2015","lastUpdatedAuto":null,"lastUpdatedManual":"05-07-2016","isContributorPI":false,"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":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Entretien t\u00e9l\u00e9phonique r\u00e9alis\u00e9 par un enqu\u00eateur professionnel, en aveugle du statut de cas ou de t\u00e9moin du sujet.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Pr\u00e9l\u00e8vement sanguin","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}