{"doc_desc":{"title":"Therapeutic options for hepatitis B and C: a French nationwide cohort study","idno":"FRESH-PEF3286-en","producers":[{"name":"Fabrice CARRAT","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3286-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3286"},{"agency":"FReSH","code":"FRESH-PEF3286"}]},"title":"Therapeutic options for hepatitis B and C: a French nationwide cohort study","alternate_title":"HEPATHER"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Stanislas;POL","PILabo":"Assistance Publique des H\u00f4pitaux de Paris \/ U1016 Institut COCHIN- EMC - R\u00e9g\u00e9n\u00e9ration, plo\u00efdie et senescence dans la pathophysiologie h\u00e9patique","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"032856520","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200217519N","role":"labo id"}],"email":"stanislas.pol@aphp.fr","isContact":"Yes"},{"type":"investigator","name":"Fabrice;CARRAT","PILabo":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - \/ Unit\u00e9 INSERM UMR-S 707: \u00c9pid\u00e9miologie, Syst\u00e8mes d'Information, Mod\u00e9lisation Equipe : Epid\u00e9miologie des maladies infectieuses et mod\u00e9lisation","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-8672-7918","role":"pi id"},{"title":"IdRef","uri":"061656720","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"200616418Z","role":"labo id"}],"email":"fabrice.carrat@iplesp.upmc.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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"},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","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":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]}]},"distribution_statement":{"contact":[{"name":"Stanislas;POL","email":"stanislas.pol@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":"Fabrice;CARRAT","email":"fabrice.carrat@iplesp.upmc.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"}]}]},"study_info":{"keywords":[{"keyword":"Therapeutics"},{"keyword":"Virology"},{"keyword":"Pathology and Physiopathology"},{"keyword":"Public health"},{"keyword":"antiviral HBV therapies"},{"keyword":"drug resistant mutants"}],"topics":[{"topic":"Infectious disease medicine","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":"Hepatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The HEPATHER project aims to set-up a cohort of patients with viral hepatitis B or C in order to improve management and care, givin the changing era of therapeutic options as news drugs come on the market. A major scientific and public-health challenge will be to improve quality of medical care in chronic hepatitis taking into account the different treatment options and host characteristics. The objectives of this cohort will be: - To describe the epidemiology of these chronic infection at a period when screening of viral infection and early diagnosis increase, and genetic and research of biomarkers of disease progression or treatment success are rapidly evolving; -To obtain original data on efficacy and safety of new hepatitis treatments in real-life, on a large size of patients, with a long term follow-up, allowing to estimate the public health impact of these treatments in terms of reduction of morbidity or mortality; - To study the relative effects of treatments to determine, at the level patient, which will be most likely to improve overall health and to limit emergence of variants and breakthrough; - To elaborate and compare cost-effectiveness strategies for the management and treatment of chronic HCV and HBV infections ; - To offer outstanding competency and ressources for the design of clinical trials on specific sub-population This project got an original governance including academic and regulatory institutions as well as pharmaceutical industries and patients associations","abstract":"","coll_dates":[{"start":"2012-01-01"}],"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\": \"HBV-positive patients - chronic hepatitis B defined by a positive HBs Ag for at least 6 months, with less than 50% of inactive carriers - acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag, with or without association with acute or chonic hepatitis D  HCV-positive patients - chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months, and positive HCV-RNA, - acute hepatitis B defined by the recent appearance of HCV RNA (<6 months) in patients with risk factors (with or without positives antibodies) - patients with cured hepatitis C defined by lond term radication, either treatment, either spontaneous, a positive anti-HCV antibodies associated to a negative  RNA at two collection - 6 months interval time (this patients should represent less than 10% patients).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"- 15,000 patients \/ h\u00e9patite C c- 10,000 patients \/ h\u00e9patite B c"},"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":"Accessibility of the database will be determined case by case by the executive committee in agreement with the scientific committee. The intellectual property and contractual issues will be managed by Inserm Transfert. Special attention will be paid on confidentiality, ethical issues and on the use of the biobank to yield the greatest scientific value to the community and avoid depletion of this finite ressource. The proposal will be examined by the executive committee. The committee will assist academic and private researchers with queries and will advise on data quality, study design and data analysis if necessary. The committee will ensure the coherence with other projects. The executive committee will evaluate methodological aspects and scientific relevance based on reports from the scientific committee. Independent external experts will provide advice on decisions relative to access rights, for example on issues related to the access on one industrial to data linked to the product of another industrial. It will prioritize projects. In preparation for data sharing, much attention will be paid to the wording within subject consent documents. The flexibility of web-based database will also facilitate the addition of new questionnaires for ancillary studies.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":"The executive committee will establish policies to facilitate data sharing and to provide a mechanism for tracking publications related to and resulting from Hepather data. Moreover the executive committee will monitor contributions of the ancillary studies to the community and will require results to be incorporated into a resource database for use by other researchers."},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"29-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"21-05-2012","isContributorPI":"No","contributorName":"Fabrice CARRAT","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=(hepather+NOT+heather)+AND+Carrat+F%5BAuthor%5D"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Retrospective and prospective data will be collected with an anticipated follow-up of 10 years to allow analyzing the epidemiology, treatment hisory, genetic and environmental risk factors of disease progression, interactions between these factors and various individual and public health outcomes.When a eligible patient arrives at the assessment he\/she will move through a series of assessment involving questionnaires, measurements, and blood\/urine\/feces sampling. During the visit, detailed demographics, clinical, biological and virological data will be collected. In each participing center, the existing database (if any) and the capacities of extracting and importing data from the database into the dedicated information system will be investigated. It is expected that 80% of historical patient data in the cohort would be imported from existing medical files.The general approach of follow-up will be to combine systematic follow-up visits for particular events (such as clinical event or initiation of therapy) with using a variety of different national administrative databases and sources to ascertain death and other health related information, using support of the PLASTICO plateforme.The devoted information system will allow patient to self report on various items and most notably QoL studies.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"30 clinical centers widespread in France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"hepatitis followvirology","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}