Status:
RECRUITING
Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD
Lead Sponsor:
University Hospital, Angers
Conditions:
NAFLD
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of pa...
Detailed Description
FIB4-FS and the eLIFT-FMVCTE were previosuly directly compared in a database of biopsy-proven NAFLD patients. These two algorithms showed a very good \>80% diagnostic accuracy for advanced fibrosis an...
Eligibility Criteria
Inclusion
- 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).
- Age ≥18 years and ≤80 years
- Affiliated person or beneficiary of a social security regime
- Written informed consent of the patient who agree to comply with the study protocol.
Exclusion
- Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome)
- Hepatocellular carcinoma
- Inability to safely undergo liver biopsy
- 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.
- Pregnant, breastfeeding or parturient woman
- Person restricted by judicial or administrative decision
- Person under psychiatric care under restraint
- Person subject to a legal protection measure
- Person unable to express consent
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 7 2028
Estimated Enrollment :
1045 Patients enrolled
Trial Details
Trial ID
NCT04681573
Start Date
April 7 2022
End Date
December 7 2028
Last Update
November 18 2025
Active Locations (20)
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1
University Hospital of Angers
Angers, France
2
University Hospital of Besançon
Besançon, France
3
Avicenne Hospital (Greater Paris University Hospitals)
Bobigny, France
4
University Hospital of Dijon
Dijon, France