{"study_desc":{"title_statement":{"idno":"FRESH-PEF73987-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73987"},{"agency":"FReSH","code":"FRESH-PEF73987"}]},"title":"\u00c9TUDE NATIONALE EN VIE R\u00c9ELLE SUR LES LYMPHOMES","alternate_title":"REALYSA"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Herv\u00e9;GHESQUIERES","firstname":"Herv\u00e9","lastname":"GHESQUIERES","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"uri":"0000-0002-3131-3718","role":"pi id","title":"ORCID"},{"uri":"067203779","role":"pi id","title":"IdRef"}],"email":"","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"Hospices Civils de Lyon - LYSA , The Lymphoma Study Association \/ Service d'h\u00e9matologie clinique","isContact":false},{"name":"Fanny;CHERBLANC","firstname":"Fanny","lastname":"CHERBLANC","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0106jdf02","role":"organisation id"},{"title":"SIREN","uri":"432730919","role":"organisation id"}],"email":"fanny.cherblanc@lysarc.org","affiliationName":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","PILabo":"LYSARC \/ Management de Projets","isContact":true}],"oth_id":[{"name":"Interlymph","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","lastname":"CHERBLANC","firstname":"Fanny","type":"contact","email":"fanny.cherblanc@lysarc.org","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":"Facteurs pronostics"},{"keyword":"Prise en charge th\u00e9rapeutique"},{"keyword":"Biobanques"},{"keyword":"Etude prospective"},{"keyword":"Multicentrique"},{"keyword":"Exposition environnementale"},{"keyword":"exposition professionnelle"},{"keyword":"Parcours de soins"},{"keyword":"Pesticides"}],"topics":[{"topic":"H\u00e9matologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"D006402"}]},{"topic":"Tumeurs de tissus h\u00e9matopo\u00ef\u00e9tiques ou lympho\u00efdes","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Mettre en place une plateforme \u00e9pid\u00e9miologique en vie r\u00e9elle des lymphomes en France \u00e0 vis\u00e9e pronostique incluant des donn\u00e9es \u00e9pid\u00e9miologiques, cliniques et biologiques avec un suivi prospectif des patients jusqu\u2019\u00e0 9 ans.","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":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Les crit\u00e8res d\u2019inclusion sont : avoir donn\u00e9 son consentement \u00e9crit ; \u00eatre \u00e2g\u00e9 de plus de 18 ans ; avoir \u00e9t\u00e9 diagnostiqu\u00e9 d\u2019un lymphome dans les 6 derniers mois parmi les 7 sous types suivants : LDGCB, LF, lymphome des cellules du manteau, lymphome de la zone marginale, lymphome T, LH, lymphome de Burkitt.  \",\"clusion_E\":\"avoir d\u00e9j\u00e0 re\u00e7u un traitement pour le lymphome (en dehors d\u2019une pr\u00e9-phase) ; \u00eatre infect\u00e9 par le VIH ; avoir certains sous-types de lymphomes comme les lymphomes c\u00e9r\u00e9braux, les lymphomes cutan\u00e9s, les lymphomes post-transplantation, les lymphomes lymphocytiques, la maladie de Waldenstr\u00f6m\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques (hors biologiques)','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","quality_statement":{"standards":[{"name":"['Classification OMS 2016 pour le diagnostic, extrait de MEDRA pour les \u00e9v\u00e8nements ind\u00e9sirables']","committee":"","governance":""}],"other_quality_statement":"['Validation des donn\u00e9es au sein de eCRF (queries), test de coh\u00e9rence sous SAS, contr\u00f4le qualit\u00e9 par \u00e9chantillonnage avec confrontation au dossier source']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[1000-10000[ individus","response_rate":"6000"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Tout projet doit \u00eatre valid\u00e9 par le Comit\u00e9 Scientifique de REALYSA et approuv\u00e9 par le Bureau du LYSA, sur la base d'un synopsis (trame disponible sur demande). Le Comit\u00e9 Scientifique de REALYSA se r\u00e9unit tous les trimestres. Un contrat sera \u00e9tabli pour chaque projet.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"----","lastUpdatedManual":"20-06-2025","isContributorPI":"","contributorName":"Fanny CHERBLANC","contributorAffiliation":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":["",""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"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":"Donn\u00e9es cliniques extraites du dossier m\u00e9dical par ARC des services h\u00e9matologie, Auto-questionnaire et questionnaire en entretien pour les expositions professionnelles et domestiques. Coh\u00e9rence des donn\u00e9es valid\u00e9e par test automatique et revue de cas pour validation m\u00e9dicale.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":true},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Ant\u00e9c\u00e9dents, Traitement en cours, Diagnostic, Bilan d'extension, Traitements re\u00e7us (cycle \u00e0 cycle), Arr\u00eat de traitement, Evaluations, Progression, second cancer, D\u00e9c\u00e8s","biologicalDataDetails":"Constitution d'une biobanque - Analyse biologiques sur projets","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}