Comparing two non-invasive strategies to diagnose advanced liver fibrosis in NAFLD

Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD

This tests whether two non‑invasive algorithms using routine blood tests, with or without FibroScan, can best detect advanced liver fibrosis in adults with NAFLD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1045 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Hospital, Angers (Government)
• Drugs / interventions: methotrexate
• Locations: 20 sites (Angers and 19 other locations)
• Trial ID: NCT04681573 on ClinicalTrials.gov

What this trial studies

This multicenter interventional protocol compares two diagnostic algorithms (FIB4-FS and eLIFT-FMVCTE) for identifying advanced liver fibrosis in adults with NAFLD. Participants undergo routine blood tests and, where available, liver stiffness measurement (FibroScan) and results are compared against the reference diagnostic pathway used in specialist centers. The trial aims to validate prior findings from the population where eLIFT-FMVCTE was developed to avoid optimism bias. The goal is to identify which algorithm provides the best balance of accuracy and minimal need for liver biopsy in everyday clinical practice.

Who should consider this trial

Good fit: Adults aged 18–80 with imaging‑proven hepatic steatosis, minimal alcohol intake, no other chronic liver disease, and who can provide informed consent are eligible candidates.

Not a fit: Patients with decompensated cirrhosis, other chronic liver diseases, significant alcohol use, or those already requiring specialist hepatology care are unlikely to benefit from these non‑invasive algorithms.

Why it matters

Potential benefit: If successful, the preferred algorithm could more accurately identify patients with advanced fibrosis and reduce the number of invasive liver biopsies.

How similar studies have performed: Previous internal comparisons found eLIFT-FMVCTE had modestly higher diagnostic accuracy than FIB4-FS (~84.6% vs 80.6%) but those results need external validation due to potential optimism bias.

Eligibility criteria

Inclusion Criteria:

1. Presence of NAFLD as defined by :

   * The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or Controlled Attenuation Parameter (≥248 dB/m)
   * The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen)
   * The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women)
   * The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency).
2. Age ≥18 years and ≤80 years
3. Affiliated person or beneficiary of a social security regime
4. Written informed consent of the patient who agree to comply with the study protocol.

Exclusion Criteria:

1. Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
2. Hepatocellular carcinoma
3. Inability to safely undergo liver biopsy
4. Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study.
5. Pregnant, breastfeeding or parturient woman
6. Person restricted by judicial or administrative decision
7. Person under psychiatric care under restraint
8. Person subject to a legal protection measure
9. Person unable to express consent

Where this trial is running

Angers and 19 other locations

• University Hospital of Angers — Angers, France (Recruiting)
• University Hospital of Besançon — Besançon, France (Not_yet_recruiting)
• Avicenne Hospital (Greater Paris University Hospitals) — Bobigny, France (Not_yet_recruiting)
• University Hospital of Dijon — Dijon, France (Recruiting)
• Departemental Hospital Center of Vendée — La Roche-sur-Yon, France (Recruiting)
• University Hospital of Grenoble — La Tronche, France (Active_not_recruiting)
• University Hospital of Lille — Lille, France (Active_not_recruiting)
• University Hospital of Limoges — Limoges, France (Active_not_recruiting)
• Edouard Herriot Hospital — Lyon, France (Not_yet_recruiting)
• La Croix Rousse Hospital — Lyon, France (Recruiting)
• Saint Joseph Hospital — Marseille, France (Not_yet_recruiting)
• University Hospital of Montpellier — Montpellier, France (Recruiting)
• University Hospital of Nantes — Nantes, France (Active_not_recruiting)
• Cochin Hospital — Paris, France (Not_yet_recruiting)
• La Pitié Salpétrière Hospital (Greater Paris University Hospitals) — Paris, France (Not_yet_recruiting)
• Saint-Antoine Hospital (Greater Paris University Hospitals) — Paris, France (Active_not_recruiting)
• University Hospital of Bordeaux — Pessac, France (Active_not_recruiting)
• University Hospital of Rennes — Rennes, France (Active_not_recruiting)
• University Hospital of Tours — Tours, France (Active_not_recruiting)
• University Hospital of Nancy — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Jérôme Boursier, MD-PHD

Conditions NAFLD; diagnosis; AdvanCed Liver Fibrosis