{"doc_desc":{"title":"Collaboration inter-cohortes et centres cliniques de sujets co-infect\u00e9s par les virus de l'immunodeficience humaine et de l'h\u00e9patite C","idno":"FRESH-PEF3626-fr","producers":[{"name":"Laure ESTERLE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3626-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3626"},{"agency":"FReSH","code":"FRESH-PEF3626"}]},"title":"Collaboration inter-cohortes et centres cliniques de sujets co-infect\u00e9s par les virus de l'immunodeficience humaine et de l'h\u00e9patite C","alternate_title":"ANRS C013 HEPAVIH"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Laure;ESTERLE","PILabo":"Inserm \/ INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, \u00e9quipe Morpheus, CMG-EC","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-1017-1327","role":"pi id"},{"title":"IdRef","uri":"144303140","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201622170H","role":"labo id"}],"email":"","isContact":"Non"},{"type":"investigator","name":"Dominique;SALMON","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descartes \/ Services des Maladies Infectieuses et Tropicales","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"19920814X","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201722478N","role":"labo id"}],"email":"dominique.salmon@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Philippe;SOGNI","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descarte, Inserm \/ Service d'H\u00e9patologie","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"076006824","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.sogni@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor 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":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"Linda;WITTKOP","email":"linda.wittkop@u-bordeaux.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Dominique;SALMON","email":"dominique.salmon@aphp.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Philippe;SOGNI","email":"philippe.sogni@aphp.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Adultes"},{"keyword":"porteurs"},{"keyword":"gu\u00e9ris"},{"keyword":"traitement"},{"keyword":"co-infection"}],"topics":[{"topic":"Immunologie m\u00e9dicale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"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":"Maladie due au VIH stade clinique 2 sans mention de tuberculose ni de paludisme","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1575370503","title":"CIM-11"}]},{"topic":"H\u00e9patite virale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/985510409","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"A court terme: - D\u00e9crire les caract\u00e9ristiques des patients - Analyser les facteurs associ\u00e9s \u00e0 une prise en charge de l'h\u00e9patite C, \u00e0 la mise sous traitement, \u00e0 la poursuite ou \u00e0 l'arr\u00eat du traitement - Valider la performance sur terrain des marqueurs non invasifs de fibrose h\u00e9patique A moyen terme: - R\u00e9aliser une \u00e9tude observationnelle de l'\u00e9volution des h\u00e9patites sous traitement anti VHC dans le contexte des antiviraux - \u00c9tudier la tol\u00e9rance clinique et biologique aux diff\u00e9rents traitements - \u00c9tudier l'impact de l'observance de traitement anti VIH et la qualit\u00e9 de vie des patients A long terme: - \u00c9tudier l'histoire naturelle des h\u00e9patites chroniques, en particulier au stade de cirrhose - Analyser les facteurs associ\u00e9s \u00e0 l'\u00e9volution vers la fibrose, vers une maladie h\u00e9patique d\u00e9compens\u00e9e ou un carcinome h\u00e9patocellulaire - \u00c9valuer les effets des antir\u00e9troviraux sur l'\u00e9volution des h\u00e9patites non trait\u00e9es - \u00c9tudier les interactions potentielles entre les diff\u00e9rent virus des h\u00e9patites","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2018-01-01"}],"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            \"value\": \"Autre\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adultes infect\u00e9s par le VIH porteurs du VHC ou gu\u00e9ris apr\u00e8s traitement anti-VHC, ou gu\u00e9ris spontan\u00e9s en absence de traitement anti-VHC ou b\u00e9n\u00e9ficiant d\u2019une trith\u00e9rapie anti-VHC\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"['-----']","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence au moment de la saisie des donn\u00e9es informatiques et apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Relance des sujets pour r\u00e9aliser les visites de suivi. R\u00e9alisation d\\'audit qualit\u00e9 interne.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation 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":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1850"},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation possible des donn\u00e9es par des industriels","conditions":"Condition d'acc\u00e8s (temporelles) acceptation du projet par le conseil scientifique","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"09-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2019","isContributorPI":"Non","contributorName":"Dominique SALMON","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industrie","Industrie","Public (France)","Industrie","Industrie"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier Examens cliniques : saisie manuelleExamens biologiques : saisie manuelle","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte fran\u00e7aise mutlicentrique (28 centres)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi Informations recueillies lors de l'examen clinique : poids, taille, tour de taille, tour de hanches","biologicalDataDetails":"Bilan sanguin","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}