[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcoholic-liver-disease-ald\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcoholic-liver-disease-ald":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100492966","screening-in-primary-care-of-advanced-liver-fibrosis-in-nafld-andor-alcoholic-patients-100492966",false,"NCT05699018","Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and\u002For Alcoholic Patients","SOPRANO","Inclusion Criteria:\n\n* NAFLD and\u002For ALD patient defined by at least 1 of the following criteria:\n\n  * Excessive alcohol consumption: higher than 210 g \u002F week (men), or 140 g \u002F week (women)\n  * Type 2 diabetes\n  * at least 2 metabolic factors among BMI higher than or equal to 25 kg \u002F m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg\u002Fdl (men) \u002F 50mg\u002Fdl (women), or triglycerides higher than or equal to150mg\u002Fdl); Hyperferritinemia (higher than upper limit of normal from the laboratory)\n  * Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)\n\nFollowing a protocol amendment, the 3 last investigating primary care centres will include NAFLD and\u002For ALD patients according to these updated criteria:\n\n* Excessive alcohol consumption: \\>210 g\u002Fweek in men or \\>140 g\u002Fweek in women,\n* AND\u002FOR type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments,\n* AND with the following stratification:\n\n  30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and\u002For at least two other anti-diabetic treatments)\n* Patient's agreement to have a blood sample collected in a local laboratory participating in the study\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n\nExclusion Criteria:\n\n* Already ongoing specialized follow-up for a chronic liver disease\n* Altered health status with poor short-term prognosis, not compatible with a screening procedure\n* Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)\n* Acute infection\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure\n* Person unable to express consent","ALL","40 Years","80 Years",{"count":20,"type":21},1788,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and\u002For ALD from primary care centers.",[27,28,29],"Non-alcoholic Fatty Liver Disease (NAFLD)","Alcoholic Liver Disease (ALD)","Liver Fibrosis","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2023-03-13",{"date":38,"type":21},"2026-09-12",{"name":40,"class":41},"University Hospital, Angers","OTHER_GOV",13,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100643589","elastography-based-brief-alcohol-intervention-in-hospitalized-individuals-100643589","NCT07637539","Elastography-based Brief Alcohol Intervention in Hospitalized Individuals","Proactive Liver Disease Assessment and Brief Intervention Among Hospitalized People With Harmful Alcohol Consumption: An Investigator-initiated, Pragmatic, Parallel-group, Open-label, 2-arm Randomized Controlled Trial to Investigate the Efficacy of Proactive Elastography-based Brief Alcohol Intervention Compared With Usual Care in Hospitalized Adult Participants at Risk of Alcohol-related Liver Disease","PREDILECTION","Inclusion Criteria:\n\n1. Emergency hospitalized for any reason in any participating centre\n2. Adults 18 years or older\n3. Harmful alcohol use, defined as AUDIT-C ≥6 (for men) or AUDIT-C ≥5 (for women)\n4. Moderate to high risk of liver fibrosis, defined as FIB-4 \\>1.3\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Decompensated liver disease that impedes intervention delivery, defined as one or more of the following:\n\n   1. Moderate or severe ascites\n   2. Overt hepatic encephalopathy (West Haven grade ≥2)\n   3. Acute-on-chronic liver failure requiring admission to intensive care unit\n2. Acute hepatitis of any aetiology, defined as ALT or AST \\>5 x upper limit of normal (ULN)\n3. Unable to participate for any reason in the opinion of the investigator","18 Years",{"count":53,"type":21},500,[24],"Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.",[28,57],"Alcohol Use Disorder",[59,60,61,62,63,64,65,66,67,68],"alcohol","brief intervention","brief alcohol intervention","elastography","liver fibrosis","alcohol use disorder","alcoholic liver disease","ALD","BAI","proactive liver disease assessment","NOT_YET_RECRUITING","2026-06-04",{"date":72,"type":34},"2026-06-09",{"date":74,"type":21},"2026-08-15",{"date":76,"type":21},"2038-05-15",{"name":78,"class":79},"Oslo University Hospital","OTHER",8]