{"doc_desc":{"title":"NATIONAL REAL-LIFE STUDY OF LYMPHOMAS","idno":"FRESH-PEF73987-en","producers":[{"name":"Fanny CHERBLANC","affiliation":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73987-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73987"},{"agency":"FReSH","code":"FRESH-PEF73987"}]},"title":"NATIONAL REAL-LIFE STUDY OF LYMPHOMAS","alternate_title":"REALYSA"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Herv\u00e9;GHESQUIERES","PILabo":"Hospices Civils de Lyon - LYSA , The Lymphoma Study Association \/ Service d'h\u00e9matologie clinique","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ORCID","uri":"0000-0002-3131-3718","role":"pi id"},{"title":"IdRef","uri":"067203779","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Fanny;CHERBLANC","PILabo":"LYSARC \/ Management de Projets","affiliationName":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"432730919","role":"organisation id"},{"title":"RNSR","uri":"201722263E","role":"labo id"}],"email":"fanny.cherblanc@lysarc.org","isContact":"Yes"}],"oth_id":[{"name":"Interlymph","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"},{"name":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0106jdf02","role":"sponsor id"},{"title":"SIREN","uri":"432730919","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Fanny;CHERBLANC","email":"fanny.cherblanc@lysarc.org","type":"contact","affiliationName":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0106jdf02","role":"organisation id","title":"ROR"},{"uri":"432730919","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Prognostic factors"},{"keyword":"Therapeutic management"},{"keyword":"Biobanks"},{"keyword":"Prospective study"},{"keyword":"Multicentric"},{"keyword":"Environmental exposure"},{"keyword":"Occupational exposure"},{"keyword":"Care pathway"},{"keyword":"Pesticides"}],"topics":[{"topic":"Hematology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Neoplasms of haematopoietic or lymphoid tissues","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Set up a real-life epidemiological platform for lymphoma prognosis in France, including epidemiological, clinical and biological data, with prospective follow-up of patients for up to 9 years.","abstract":"","coll_dates":[{"start":"2018-01-01","end":"2028-01-01"}],"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            \"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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"['WHO 2016 diagnostic classification, MEDDRA extract for adverse events']","committee":"","governance":""}],"other_quality_statement":"['Data validation within eCRF (queries), consistency test in SAS, quality control by sampling with comparison to the source file']"}},"study_development":{"development_activity":[]},"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":"","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"","response_rate":"6000"},"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":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"All projects must be validated by the REALYSA Scientific Committee and approved by the LYSA Board, on the basis of a synopsis (available on request). The REALYSA Scientific Committee meets quarterly. A contract will be drawn up for each project.","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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":"No","contributorName":"Fanny CHERBLANC","contributorAffiliation":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)","Private non-profit"],"otherSponsorType":["",""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"Clinical data extracted from medical records by ARC from haematology departments, self-questionnaires and interview questionnaires for occupational and domestic exposures. Data consistency validated by automatic testing and case review for medical validation.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Establishment of a biobank - Biological analysis on projects","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}