Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
Key facts
- Where
- Angers, Baugé-en-Anjou, Bécon-les-Granits, Chalonnes-sur-Loire, Combourg, Liffré, Montreuil-Bellay, Rennes, Segré, and Val-couesnon, FranceSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT05699018, who can take part
Where in France
- ANGERSAngers, FranceNo longer taking part
- CHU AngersAngers, FranceNo longer taking part
- BAUGEBaugé-en-Anjou, FranceTaking people
- BECONBécon-les-Granits, FranceNo longer taking part
- ChalonnesChalonnes-sur-Loire, FranceNo longer taking part
- COMBOURGCombourg, FranceNo longer taking part
- LIFFRELiffré, FranceNo longer taking part
- MontreuilMontreuil-Bellay, FranceNo longer taking part
- CHU RennesRennes, FranceNo longer taking part
- RENNES - Armagnac, ChurchillRennes, FranceNo longer taking part
- RENNES - KennedyRennes, FranceNo longer taking part
- SEGRESegré, FranceNo longer taking part
- Val CouesnonVal-couesnon, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Angers
- Trial code
- NCT05699018
- Record updated
- 30 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Already ongoing specialized follow-up for a chronic liver disease; Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome); Acute infection; 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.