{"study_desc":{"title_statement":{"idno":"FRESH-PEF73235-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73235"},{"agency":"FReSH","code":"FRESH-PEF73235"}]},"title":"Retrospective study of Guadeloupean kidney transplant patients: incidence of cancer","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Nad\u00e8ge;CORDEL","firstname":"Nad\u00e8ge","lastname":"CORDEL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04sfmcd28","role":"organisation id"},{"title":"SIREN","uri":"269710414","role":"organisation id"},{"uri":"108964000","role":"pi id","title":"IdRef"}],"email":"nadege.cordel@chu-guadeloupe.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE POINTE-A-PITRE","PILabo":"Centre hospitalier universitaire de Pointe-\u00e0-Pitre \/ EA 4546- CELTEC","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE POINTE-A-PITRE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04sfmcd28","role":"sponsor id"},{"title":"SIREN","uri":"269710414","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE POINTE-A-PITRE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04sfmcd28"},{"title":"SIREN","uri":"269710414"}]}]},"distribution_statement":{"contact":[{"name":"Nad\u00e8ge;CORDEL","lastname":"CORDEL","firstname":"Nad\u00e8ge","type":"contact","email":"nadege.cordel@chu-guadeloupe.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE POINTE-A-PITRE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04sfmcd28","role":"organisation id","title":"ROR"},{"uri":"269710414","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Afro-Caribbean"},{"keyword":"Cancer"},{"keyword":"Transplantation"},{"keyword":"West Indies"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"Nephrology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"D009398"}]},{"topic":"Neoplasms","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1630407678","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The main objective of this study was to estimate the incidence of cancers in these patients; the secondary objective was to specify their cancer predisposition factors.","abstract":"","coll_dates":[{"start":"2004-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Guadeloupe']","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Aged, 80 and over (80 years and more)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"The study included Guadeloupean patients from phototype V to VI, having undergone a kidney transplant between 01\/01\/2004 and 31\/12\/2011\",\"clusion_E\":\"\"}","data_kind":"['Clinical 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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"102"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"30-09-2015","lastUpdatedManual":"14-09-2017","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26283424"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"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":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Guadeloupe"},"dataTypes":{"clinicalDataDetails":"screening for skin cancers, annual post-transplant dermatological consultation, clinical symptomatology, screening tests advocated by current recommendations","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"}