{"doc_desc":{"title":"Cohorte de patients atteints d'H\u00e9patite Aigu\u00eb S\u00e9v\u00e8re de cause Ind\u00e9termin\u00e9e","idno":"FRESH-PEF8360-fr","producers":[{"name":"Jean-Charles DUCLOS-VALLEE","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8360-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8360"},{"agency":"FReSH","code":"FRESH-PEF8360"}]},"title":"Cohorte de patients atteints d'H\u00e9patite Aigu\u00eb S\u00e9v\u00e8re de cause Ind\u00e9termin\u00e9e","alternate_title":"HASI-PRO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Audrey;COILLY","PILabo":"H\u00f4pital Paul \/ Centre H\u00e9pato-Biliaire","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"14463774X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"audrey.coilly@aphp.fr","isContact":"Oui"},{"type":"investigator","name":"Jean-Charles;DUCLOS-VALLEE","PILabo":"H\u00f4pital Paul \/ Centre H\u00e9pato-Biliaire","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"131225405","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-charles.duclos-vallee@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14"},{"title":"SIREN","uri":"267500452"}]}]},"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"}]}]},"study_info":{"keywords":[{"keyword":"maladie rare"},{"keyword":"fonction h\u00e9patique"},{"keyword":"cause"},{"keyword":"HAS indetermin\u00e9e"},{"keyword":"transplantation h\u00e9patique"},{"keyword":"crit\u00e8res de transplantation"},{"keyword":"anticorps"},{"keyword":"toxicologie"},{"keyword":"survie."},{"keyword":"\u00e9tiologie"},{"keyword":"g\u00e9n\u00e9tique"}],"topics":[{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"Insuffisance h\u00e9patique aig\u00fce ou subaig\u00fce","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1973223737","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"}],"purpose":"Les facteurs pronostiques connus et valid\u00e9s pour les HAS sont mis en d\u00e9faut lorsque le patient est admis pour une HASI dont le pronostic est p\u00e9joratif, y compris apr\u00e8s transplantation h\u00e9patique. La d\u00e9termination de nouveaux crit\u00e8res pronostiques propres est fondamentale pour une meilleure prise en charge et une am\u00e9lioration de la survie des patients admis pour HASI. Objectif principal : - D\u00e9terminer les facteurs pronostiques pr\u00e9coces de mortalit\u00e9 chez les patients admis pour une HASI. Objectifs secondaires : - D\u00e9crire l\u2019\u00e9volution des HASI \u00e0 3 mois. - Recherche a posteriori de causes rares d\u2019HAS : \u00e9tude g\u00e9n\u00e9tique (polymorphisme des g\u00e8nes codant les cytok\u00e9ratines 8 et 18), d\u00e9tection de nouveaux anticorps par l\u2019analyse du prot\u00e9ome s\u00e9rique, \u00e9tude toxicologique par spectrom\u00e9trie de masse.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2016-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France']","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\": \" \u00e2ge sup\u00e9rieur 18 ans - cytolyse et\\\/ou cholestase AVEC un taux de prothrombine inf\u00e9rieur \u00e0 50% ou un INR sup\u00e9rieur \u00e0 1,5 - signature du consentement \u00e9clair\u00e9 par le patient ou la personne de confiance - sans h\u00e9patipathie chronique sous-jacente - cause de HAS non identifi\u00e9e \u00e0 l'admission - non participation \u00e0 une \u00e9tude th\u00e9rapeutique susceptible de modifier le pronostic du patient\",\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\r\nConsommation de soins\/services de sant\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\":\"MeasurementsAndTests.Physical\",\"vocab\":\"CESSDA\"},\"value\":\"Mesures physiques\/biologiques (tension art\u00e9rielle, poids, biochimie, imagerie...)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"100"},"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","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":"11-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"21-08-2014","isContributorPI":"Non","contributorName":"Jean-Charles DUCLOS-VALLEE","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21465508"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"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":"Recueil syst\u00e9matique de donn\u00e9es cliniques et biologiques \u00e0 J0, J1, J2, J3, J5, J7, M1,M3 et lors de la TH (donn\u00e9es d\u00e9j\u00e0 collect\u00e9es dans le cadre du soin). Recherche \u00e9tiologique approfondie \u00e0 M1. Pr\u00e9l\u00e8vements de sang et urine \u00e0 J0 pour la constitution de collections biologiques. Cong\u00e9lation de tissu en cas de biopsie h\u00e9patique ou pr\u00e9l\u00e8vement d\u2019un \u00e9chantillon du foie natif en cas de TH.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Centre H\u00e9pato-biliaire Paul Brousse, Villejuif, France."},"dataTypes":{"clinicalDataDetails":"Taux de transplantation h\u00e9patique, survie sans transplantation, mortalit\u00e9 post-transplantation.","biologicalDataDetails":"Collection d\u2019ADN, d\u2019urine et de s\u00e9rum pour recherche ult\u00e9rieure de facteurs g\u00e9n\u00e9tiques et toxiques.","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}