NCT05699018Recruiting
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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/or ALD from primary care centers.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1788 (estimated)
- First submitted
- 28 Dec 2022
- Start date
- Mar 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- University Hospital, Angers
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05699018
What you commit to
- Study type: Interventional
- Planned participants: 1788
- From Mar 2023 to the primary completion date, Jun 2026
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Already ongoing specialized follow-up for a chronic liver disease
- Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- Acute infection
Other
- Altered health status with poor short-term prognosis, not compatible with a screening procedure
- 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
Who the study is looking for
- 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:
- 30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.