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

University Hospital, Angers

Status: Enrolling

Conditions: Screening; Advanced Liver Fibrosis

Treatments: Diagnostic Test: FIB4

Study type: Interventional

Funder types: Other

Identifiers

NCT05880173

49RC22_0399

Details and patient eligibility

About

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.

Full 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.

Enrollment: 502 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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502 participants in 1 patient group

Diagnostic FIB4

Other group

Description:

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

Treatment:

Diagnostic Test: FIB4