[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433533":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":28,"locations":19,"responsibleParty":34,"collaborators":19,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":19,"enrollmentInfo":46,"targetDuration":19,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":61,"whyStopped":19,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":19},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients","Patients with histologically confirmed NAFLD",[12,13],"Other: Biological specimens","Other: Additional visit",[15,20],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Biological specimens","Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis :\n\n* added for the research : blood, urine, stools\n* collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)",[9],null,{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":19},"Additional visit","Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)",[9],[25],{"name":26,"affiliation":5,"role":27},"Vlad RATZIU","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","0142161001","+33","vlad.ratziu@aphp.fr",{"type":35,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100433533","the-french-national-nafld-cohort-french-patients-with-metabolic-steatosis-100433533",false,"NCT04925362","THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)","Identification of Clinical and Biological Factors Determining Disease Severity and Disease Progression in NAFLD: \"THE FRENCH NATIONAL NAFLD COHORT\" FRAMES (FRench pAtients With MEtabolic Steatosis)","FRAMES","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patients with a confirmed diagnosis of NAFLD\n3. Patients affiliated to French social security\n4. Written informed consent signed by the patient\n\nExclusion Criteria:\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than 21\u002F14 units\u002Fweek (males\u002Ffemales) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose\u002Fregimen or introduction of Vitamin E (at a dose ≥400 IU\u002Fday), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-French speaking\u002Funable to access an interpreter.\n9. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).\n10. Pregnant or breastfeeding women\n11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom","ALL","18 Years",{"count":47,"type":48},900,"ESTIMATED","INTERVENTIONAL",[51],"NA","The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.\n\n* at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis\n* during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis",[54,55,56,57,58],"NAFLD","NASH","NASH - Nonalcoholic Steatohepatitis","Fibrosis","Cirrhosis",[60],"Cohort","NOT_YET_RECRUITING","2021-06-07",{"date":64,"type":65},"2021-06-14","ACTUAL",{"date":67,"type":48},"2021-06",{"date":69,"type":48},"2036-06",{"name":5,"class":6}]