{"doc_desc":{"title":"Cohort of 5,000 Patients at Risk of Melanoma","idno":"FRESH-PEF60197-en","producers":[{"name":"Jean-Michel NGUYEN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60197-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60197"},{"agency":"FReSH","code":"FRESH-PEF60197"}]},"title":"Cohort of 5,000 Patients at Risk of Melanoma","alternate_title":"COPARIME 5000"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Ga\u00eblle;QUEREUX","PILabo":"CHU \/ UNIT\u00c9 ONCODERMATOLOGIE- UMR892 UNIT\u00c9 ONCODERMATOLOGIE- UMR892","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0002-1739-1701","role":"pi id"},{"title":"IdRef","uri":"144285177","role":"pi id"},{"title":"","uri":"","role":"organisation id"},{"title":"RNSR","uri":"202023527R","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Jean-Michel;NGUYEN","PILabo":"CHU \/ SERVICE D'EPID\u00c9MIOLOGIE ET DE BIOSTATISTIQUES- CHU NANTES UMR892 ET CHU DE NANTES","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0001-8815-7640","role":"pi id"},{"title":"IdRef","uri":"087292335","role":"pi id"},{"title":"SIREN","uri":"264400136","role":"organisation id"},{"title":"RNSR","uri":"202023527R","role":"labo id"}],"email":"Jean-Michel.Nguyen@univ-nantes.fr","isContact":"Yes"},{"type":"investigator","name":"C\u00e9dric;RAT","PILabo":"UNIVERSITE DE \/ D\u00c9PARTEMENT DE M\u00c9DECINE G\u00c9N\u00c9RAL","affiliationName":"NANTES UNIVERSITE","extlink":[{"title":"ORCID","uri":"0000-0003-4556-4494","role":"pi id"},{"title":"IdRef","uri":"106997106","role":"pi id"},{"title":"SIREN","uri":"130029747","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cedric.rat@univ-nantes.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"Jean-Michel;NGUYEN","email":"Jean-Michel.Nguyen@univ-nantes.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]},{"name":"C\u00e9dric;RAT","email":"cedric.rat@univ-nantes.fr","type":"contact","affiliationName":"NANTES UNIVERSITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03gnr7b55","role":"organisation id","title":"ROR"},{"uri":"130029747","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"malignancies"},{"keyword":"immune deficiencies"},{"keyword":"autoimmune diseases"},{"keyword":"users"},{"keyword":"Health episodes"},{"keyword":"prevention"},{"keyword":"health system"}],"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"}]}],"purpose":"General objective: to estimate the risk of developing de novo melanoma for at-risk patients according to the SAMScore (Self Administrated Melanoma risk score). Secondary objective: - To describe patient epidemiological and clinical characteristics - To develop a biobank in order to facilitate studies on these diseases and to investigate the physiopathogenic, haemato-immunological and genetic mechanisms of the same. - To establish and validate national treatment guidelines according to potential patient sub-groups.","abstract":"","coll_dates":[{"start":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","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            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\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            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients having 18 years old or more and at elevated risk of melanoma.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health 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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"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":"8000"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Data may be used by academic teams. To be decided if data may be used by industrial teams.","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Contractual access conditions: project submission to the scientific council","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"11-08-2014","isContributorPI":"No","contributorName":"Jean-Michel NGUYEN","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.em-consulte.com\/article\/743618\/article\/cohorte-de-patients-a-risque-de-melanome-coparime-"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: input from a paper questionnaire Clinical examinations: direct input Biological analysis: handwritten","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Departments of Loire Atlantique and Vend\u00e9e"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}