Actively Recruiting
Comparison of Two Strategies for the Non-Invasive Diagnosis of Advanced Liver Fibrosis in NAFLD
Led by University Hospital, Angers · Updated on 2025-11-18
1045
Participants Needed
20
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-Alcoholic Fatty Liver Disease (NAFLD), which is linked to overweight and insulin resistance, affects about 25% of the global population. Identifying advanced liver fibrosis (ALF) in NAFLD is important because it marks patients with a higher risk of liver-related complications who need special care. While liver biopsy is the standard for diagnosing liver fibrosis, it is invasive and not suitable for routine use. Non-invasive tests like liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests are available, but each has limitations in accuracy, cost, and accessibility. Two combined diagnostic algorithms, FIB4-Fibroscan (FIB4-FS) and eLIFT-FibroMeterVCTE (eLIFT-FMVCTE), have been developed to improve diagnosis by sequentially using simple blood tests followed by more precise tests, reserving biopsy for unclear cases. This trial compares these two strategies for diagnosing ALF in NAFLD patients. Participants will be assessed using a single diagnostic approach involving the FIB4-FS and eLIFT-FMVCTE algorithms. Patients are divided into two groups: a low-risk group without metabolic syndrome or elevated AST levels, where liver biopsy is generally not required, and an at-risk group with metabolic syndrome or higher AST, who will undergo liver biopsy alongside clinical data collection, blood sampling, and Fibroscan on the same day. This design aims to validate and compare the accuracy and clinical usefulness of both algorithms in an independent patient group. During the study, participants will have clinical data recorded, blood samples taken, and liver stiffness measured with Fibroscan. Those in the at-risk group will also have a liver biopsy. Researchers will track how accurately each strategy classifies advanced liver fibrosis, including sensitivity and factors affecting diagnostic performance. The main outcome is the rate of correct diagnosis of advanced fibrosis within two months. Safety and other secondary outcomes related to diagnostic accuracy will also be evaluated. Participation duration varies but assessments focus on the initial diagnostic period and follow-up at two months.
CONDITIONS
Brief Title
Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with NAFLD, confirmed by liver imaging showing fat in the liver
- No use of steatosis-inducing drugs such as systemic corticosteroids, methotrexate, amiodarone, or tamoxifen
- Alcohol consumption below 210 g/week for men or 140 g/week for women
- No other chronic liver diseases like viral hepatitis B or C, hemochromatosis, autoimmune hepatitis, or Wilson disease
- Age between 18 and 80 years
- Affiliated with or beneficiary of a social security system
- Able and willing to provide written informed consent and comply with the study protocol
You will not qualify if you...
- Presence of decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Diagnosis of hepatocellular carcinoma
- Unable to safely undergo liver biopsy
- Participation in another intervention study with drug treatment ongoing or within one month prior
- Pregnant, breastfeeding, or recently gave birth
- Subject to judicial or administrative restrictions
- Under psychiatric care with restraint
- Under legal protection measures
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for clinical data recording, blood sampling, and Fibroscan
Duration - Up to 2 months
Participants undergo diagnostic tests including blood tests and Fibroscan to evaluate liver fibrosis using the FIB4-FS and eLIFT-FMVCTE algorithms. Depending on risk group, some participants may also have a liver biopsy.
1 visit (in-person) for clinical data recording, blood sampling, Fibroscan, and for at-risk participants, liver biopsy on the same day
Trial Site Locations
Total: 20 locations
1
University Hospital of Angers
Angers, France
Actively Recruiting
2
University Hospital of Besançon
Besançon, France
Not Yet Recruiting
3
Avicenne Hospital (Greater Paris University Hospitals)
Bobigny, France
Not Yet Recruiting
4
University Hospital of Dijon
Dijon, France
Actively Recruiting
5
Departemental Hospital Center of Vendée
La Roche-sur-Yon, France
Actively Recruiting
6
University Hospital of Grenoble
La Tronche, France
Active, Not Recruiting
7
University Hospital of Lille
Lille, France
Active, Not Recruiting
8
University Hospital of Limoges
Limoges, France
Active, Not Recruiting
9
Edouard Herriot Hospital
Lyon, France
Not Yet Recruiting
10
La Croix Rousse Hospital
Lyon, France
Actively Recruiting
11
Saint Joseph Hospital
Marseille, France
Not Yet Recruiting
12
University Hospital of Montpellier
Montpellier, France
Actively Recruiting
13
University Hospital of Nantes
Nantes, France
Active, Not Recruiting
14
Cochin Hospital
Paris, France
Not Yet Recruiting
15
La Pitié Salpétrière Hospital (Greater Paris University Hospitals)
Paris, France
Not Yet Recruiting
16
Saint-Antoine Hospital (Greater Paris University Hospitals)
Paris, France
Active, Not Recruiting
17
University Hospital of Bordeaux
Pessac, France
Active, Not Recruiting
18
University Hospital of Rennes
Rennes, France
Active, Not Recruiting
19
University Hospital of Tours
Tours, France
Active, Not Recruiting
20
University Hospital of Nancy
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
J
Jérôme Boursier, MD-PHD
M
Marc de Saint Loup
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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