{"doc_desc":{"title":"\u00c9TUDE NATIONALE EN VIE R\u00c9ELLE SUR LES LYMPHOMES","idno":"FRESH-PEF73987-fr","producers":[{"name":"Fanny CHERBLANC","affiliation":"LYSARC - THE LYMPHOMA ACADEMIC RESEARCH ORGANISATION"}]},"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"}],"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":"http:\/\/id.nlm.nih.gov\/mesh\/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":"Syst\u00e8mes de soins et 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":"{\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            \"value\": \"F\u00e9minin\",\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\": \"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            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"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.  \",\n    \"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\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","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 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Le Comit\u00e9 Scientifique de REALYSA se r\u00e9unit tous les trimestres. 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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"}