SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population

NCT ID: NCT05880173

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2027-03-31

Brief Summary

The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation.

Detailed Description

Chronic liver diseases are insidious diseases characterized by inflammation of the liver parenchyma responsible for a progressive accumulation of fibrosis until cirrhosis and hepatocellular carcinoma (HCC). Cirrhosis and HCC are respectively the 11th and 16th most frequent causes of death in the world, and are responsible for 2 million deaths each year. Cirrhosis and HCC are most often diagnosed too late with a median survival of 18-24 months.

The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications (decompensation of cirrhosis, HCC) in chronic liver diseases.

Hepatic fibrosis is described in 5 stages from F0 (no fibrosis) to F4 (cirrhosis). It is well accepted that patients with advanced hepatic fibrosis (F3 and F4) are at the highest risk of developing complications of cirrhosis and/or HCC. It is therefore necessary to identify these patients in order to offer them specialized management.

Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis, essentially the fibrosis blood test (FIB4) and liver elastometry devices (fibroScan). The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters (ASAT, ALAT, platelets). The recommendations of French, European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test.

To facilitate screening by general practitioners, several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests, including platelets, AST and ALT, without regard to the patient's risk factors for liver disease. This approach is not in concordance with the recommendations of the scientific societies (targeted screening in patients with hepatic risk factors) and needs to be evaluated.

The purpose of this study is to evaluate if the procedure for diagnosing hepatic fibrosis implemented by some local laboratories and based on an automated calculation of FIB4 is pertinent.

Conditions

Screening; Advanced Liver Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Diagnostic FIB4

Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference

Group Type: OTHER

FIB4

Intervention Type: DIAGNOSTIC_TEST

Diagnostic procedure :

FIB4 blood tests in medical analysis laboratories. If FIB4 positive, Non invasive spacialized evaluation (transient elastography and FibroMeter) by a specialist and if necessery liver biopsy, endoscopy and/or echography

Interventions

FIB4

Diagnostic procedure :

FIB4 blood tests in medical analysis laboratories. If FIB4 positive, Non invasive spacialized evaluation (transient elastography and FibroMeter) by a specialist and if necessery liver biopsy, endoscopy and/or echography

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 70 years
• Blood sample taken at a medical testing laboratory selected for the study.
• Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.)
• FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old
• Signature of informed consent to participate in the study

Exclusion Criteria

• Ongoing specialized follow-up for a chronic liver disease
• Difficulty understanding the French language
• Pregnant women, breastfeeding or parturient women
• Persons suspended from liberty by judicial or administrative decision
• Persons under legal protection
• Persons unable to express their consent
• Non affiliation to a social security system

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Angers

Angers, , France

Site Status: NOT_YET_RECRUITING

Chu Bordeaux

Angers, , France

Site Status: NOT_YET_RECRUITING

Chu Grenoble Alpes

Grenoble, , France

Site Status: RECRUITING

Centre Hospitalier de Lens

Lens, , France

Site Status: RECRUITING

Hopital Saint Joseph

Marseille, , France

Site Status: NOT_YET_RECRUITING

Chu Nancy

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Clémence CANIVET, MD, PHD

Role: CONTACT

clemence.canivet@chu-angers.fr

(0)241353142 ext. +33

Matthieu LE LAY

Role: CONTACT

matthieu.lelay@chu-angers.fr

(0)241355891 ext. +33

Facility Contacts

Clémence CANIVET, MD, PHD

Role: primary

clemence.canivet@chu-angers.fr

(0)241353142 ext. +33

Marc DE SAINT LOUP

Role: backup

madesaintloup@chu-angers.fr

(0)241357812 ext. +33

Victor DE LEDINGHEN

Role: primary

victor.deledinghen@chu-bordeaux.fr

(0)557656995 ext. +33

Charlotte COSTENTIN

Role: primary

CCostentin@chu-grenoble.fr

(0)476765441 ext. +33

Flavien DAUTRECQUE

Role: primary

flavien.dautrecque@gmail.com

(0)321691213 ext. +33

Marc BOURLIERE

Role: primary

mbourliere@hopital-saint-joseph.fr

(0)491808207 ext. +33

Jean-Pierre BRONOWICKI

Role: primary

jp.bronowicki@chu-nancy.fr

(0)383153359 ext. +33

Other Identifiers

49RC22_0399

Identifier Type: -

Identifier Source: org_study_id