Screening in Primary Care of Advanced Liver Fibrosis in NAFLD And/or Alcoholic Patients

Launched by UNIVERSITY HOSPITAL, ANGERS · Jan 16, 2023

Keywords

ClinConnect Summary

The SOPRANO study is a clinical trial that is looking at two different blood tests, called eLIFT and FibroMeter, to see which one works better for checking advanced liver fibrosis in patients with Non-alcoholic Fatty Liver Disease (NAFLD) and Alcoholic Liver Disease (ALD). Advanced liver fibrosis is a serious condition that can lead to liver damage, and this study aims to improve how we screen for it in primary care settings, making it easier for doctors to identify patients who need further evaluation.

To participate in this trial, you may be eligible if you have been diagnosed with NAFLD or ALD, which could be due to excessive alcohol consumption, type 2 diabetes, or other metabolic factors like being overweight or having high blood pressure. Participants will need to agree to have a blood sample taken at a local lab. The study is currently recruiting participants of all genders between the ages of 14 and 29. If you join the study, you can expect to have your blood tested and contribute to important research that could help improve liver health screenings in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * NAFLD and/or ALD patient defined by at least 1 of the following criteria:
• • Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
• • Type 2 diabetes
• • at least 2 metabolic factors among BMI higher than or equal to 25 kg / 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/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
• • Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)
• Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
• • Excessive alcohol consumption: \>210 g/week in men or \>140 g/week in women,
• • AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
• * AND with the following stratification:
• • 40% with excessive alcohol consumption 40% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 20% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)
• • Patient's agreement to have a blood sample collected in a local laboratory participating in the study
• • Subjects covered by or having the rights to medical care assurance
• • Written informed consent obtained from subject
• Exclusion Criteria:
• • Already ongoing specialized follow-up for a chronic liver disease
• • Altered health status with poor short-term prognosis, not compatible with a screening procedure
• • Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
• • Acute infection
• • Pregnancy, breastfeeding
• • Persons in detention by judicial or administrative decision
• • Person admitted to a health or social establishment for purposes other than research
• • Person subject to a legal protection measure
• • Person unable to express consent