{"doc_desc":{"title":"Cohorte de patients atteints de cirrhose alcoolique compens\u00e9e et non compliqu\u00e9e: \u00e9tudie de l\u2019incidence et des facteurs pr\u00e9dictifs de survenue du carcinome h\u00e9patocellulaire (CHC)","idno":"FRESH-PEF60198-fr","producers":[{"name":"Nathalie GANNE","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60198-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60198"},{"agency":"FReSH","code":"FRESH-PEF60198"}]},"title":"Cohorte de patients atteints de cirrhose alcoolique compens\u00e9e et non compliqu\u00e9e: \u00e9tudie de l\u2019incidence et des facteurs pr\u00e9dictifs de survenue du carcinome h\u00e9patocellulaire (CHC)","alternate_title":"CIRRAL"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":""}],"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":"FONDATION ARC POUR LA RECHERCHE SUR LE CANCER","extlink":[{"title":"SIREN","uri":"752064949"}]},{"name":"INSTITUT NATIONAL DU CANCER (INCA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03m8vkq32"},{"title":"SIREN","uri":"187512777"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"cohorte nationale"},{"keyword":"ressources biologiques"},{"keyword":"donn\u00e9es cliniques"},{"keyword":"alcool"},{"keyword":"facteurs pr\u00e9dictifs"},{"keyword":"histoire naturelle"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"H\u00e9patologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/27c456a1-051a-42f6-b52a-3beff0487da7"}]},{"topic":"M\u00e9nopause","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1965418440","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : pr\u00e9ciser l'histoire naturelle du carcinome h\u00e9patocellulaire (CHC) au cours de la cirrhose alcoolique. Objectifs secondaires : - \u00e9tablir une comparaison avec la cohorte nationale de cirrhoses virales ANRS CO12 CirVir - constituer, \u00e0 partir des ressources biologiques pr\u00e9lev\u00e9es \u00e0 l'inclusion puis annuellement et des donn\u00e9es cliniques associ\u00e9es, la base d'\u00e9tude ancillaires","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2019-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient majeur pr\u00e9sentant une cirrhose alcoolique compens\u00e9e et non compliqu\u00e9e au moment de l'inclusion.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","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.Gestion des donn\u00e9es manquantes par retour au dossier source.Relance des sujets pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"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":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[500-1000[ individus","response_rate":"709 inclus dont 652 analysables"},"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 des donn\u00e9es par des \u00e9quipes acad\u00e9miques. 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