{"doc_desc":{"title":"Cohorte des patients transplant\u00e9s h\u00e9patiques pr\u00e9sentant une r\u00e9cidive virale C trait\u00e9s par un agent antiviral direct","idno":"FRESH-PEF73116-fr","producers":[{"name":"Georges-Philippe PAGEAUX","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73116-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73116"},{"agency":"FReSH","code":"FRESH-PEF73116"}]},"title":"Cohorte des patients transplant\u00e9s h\u00e9patiques pr\u00e9sentant une r\u00e9cidive virale C trait\u00e9s par un agent antiviral direct","alternate_title":"ANRS CO23 CUPILT"},"study_authorization":{"agency":[{"name":"ANSM"}]},"authoring_entity":[{"type":"investigator","name":"Audrey;COILLY","PILabo":"Paul Brousse Hepatobiliary Centre \/ Joint Research Unit U785","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi 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id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Audrey;COILLY","email":"audrey.coilly@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Jean-Charles;DUCLOS-VALLEE","email":"jean-charles.duclos-vallee@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Georges-Philippe;PAGEAUX","email":"gp-pageaux@chu-montpellier.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE MONTPELLIER (CHU)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00mthsf17","role":"organisation id","title":"ROR"},{"uri":"263400160","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"HCV"},{"keyword":"Interactions m\u00e9dicamenteuses"},{"keyword":"antiviraux \u00e0 action directe"},{"keyword":"transplantation h\u00e9patique"}],"topics":[{"topic":"Infectiologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"H\u00e9patite virale chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1469571641","title":"CIM-11"}]},{"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","vocab":"health determinant"}],"purpose":"Evaluer l\u2019efficacit\u00e9, d\u00e9finie par l\u2019obtention d\u2019une r\u00e9ponse virologique soutenue \u00e0 12 semaines apr\u00e8s l\u2019arr\u00eat du traitement, des agents antiviraux directs (AAD) avec ou sans association \u00e0 un traitement par peginterf\u00e9ron et \/ou ribavirine chez les patients transplant\u00e9s h\u00e9patiques ayant une r\u00e9cidive virale C chronique active, quelque soit le g\u00e9notype et quelque soit la r\u00e9ponse \u00e0 un traitement ant\u00e9rieur.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2022-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}}],"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\": \"Sujet \u00e2g\u00e9 de plus de 18 ans  -Transplant\u00e9 h\u00e9patique, -Infect\u00e9 par le VHC avant la transplantation, -Pr\u00e9sentant une r\u00e9cidive virale C (quelque soit le g\u00e9notype) avec un ARN du VHC d\u00e9tectable avant l\u2019inclusion, -Devant recevoir ou recevant une th\u00e9rapie antivirale par un agent antiviral direct ou ayant d\u00e9j\u00e0 termin\u00e9 le  traitement mais toujours en cours de suivi (dans la limite de 48 semaines apr\u00e8s la fin du traitement)  -Etant affili\u00e9 ou b\u00e9n\u00e9ficiaire d\u2019un r\u00e9gime de s\u00e9curit\u00e9 sociale -Ayant sign\u00e9 un consentement de participation  NB : Sont incluables  - les greffes multiples - les patients na\u00effs ou en \u00e9chec de traitement, quelque soit le sch\u00e9ma ant\u00e9rieur, avant comme apr\u00e8s la transplantation - les patients co-infect\u00e9s VIH ou VHB - tous les degr\u00e9s de fibrose h\u00e9patique\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"699"},"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\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique et le promoteur Inserm-ANRS gestion de la base de donn\u00e9es par le Centre de M\u00e9thologie et de Gestion Inserm ANRS de 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(France)"],"otherSponsorType":["","",""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"donn\u00e9es sources: dossiers m\u00e9dicaux - recueil en base de donn\u00e9es dans les services de soin","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France + Belgique"},"dataTypes":{"clinicalDataDetails":"ann\u00e9e de naissance, sexe, donn\u00e9es sur l\u2019ethnie et la couleur de peau, co-morbidit\u00e9s m\u00e9dicales non r\u00e9solues \u00e0 l\u2019inclusion, donn\u00e9es sur la pr\u00e9-transplantation, le donneur, la transplantation, donn\u00e9es sur les traitements et complications post-transplantation, taille, poids, tol\u00e9rance des traitements, traitements (- Immunosuppresseurs (recueillis jusqu\u2019\u00e0 4 semaines apr\u00e8s l\u2019arr\u00eat du traitement par AAD) - Antir\u00e9troviraux - Facteurs de croissance h\u00e9matopo\u00ef\u00e9tiques - Traitements correcteurs des EI de grade 3 et des EIG - Tout autre traitement jug\u00e9 pertinent par l\u2019investigateur )","biologicalDataDetails":"NFS, Plaquettes INR, TP Albumine ALAT, ASAT, GGT, PAL, Bilirubine totale, Cr\u00e9atinine, ARN du VHC, Concentrations r\u00e9siduelles des immunosuppresseurs, Si VIH+ : Charge virale et taux de lymphocytes 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