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

Screening Clinical Trial

— SCREANIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880173
• Other study ID #: 49RC22_0399
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Angers
• Contact: Clémence CANIVET, MD, PHD
• Phone: (0)241353142
• Email: clemence.canivet[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 75 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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Screening

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Chu Bordeaux	Angers
France	Chu Grenoble Alpes	Grenoble
France	Centre Hospitalier de Lens	Lens
France	Hopital Saint Joseph	Marseille
France	Chu Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of advanced hepatic fibrosis.	The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4> 2.67 and a FibroScan result = 8 kPa.	3 months maximum
Secondary	Determine the rate of patients requiring second-line evaluation by elastometry	The endpoint for this objective will be the rate of patients with FIB4 >2.67.	3 months maximum
Secondary	Determine the rate of patients requiring management by a liver disease specialist.	The endpoint for this objective will be the rate of patients with a FIB4 >2.67 and then a FibroScan =8.0 kPa.	3 months maximum
Secondary	Determine the average cost spent on a patient diagnosed with advanced liver fibrosis	The endpoint for this objective will be the average direct cost of all procedures performed in the screening procedure.	3 months maximum
Secondary	Determine patient adherence to the screening procedure	The endpoint for this objective will be the rate of patients performing the procedures in accordance with the screening procedure.	3 months maximum
Secondary	Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority	The endpoint for this objective will be multivariate analysis of risk factors according to the stage of detected liver fibrosis	3 months maximum
Secondary	Determine the rate of patients with a significant liver complication in the population of patients with risk factors	The endpoints for this objective will be the number of diagnosed hepatocellular carcinoma and esophageal/gastric varices with bleeding risk.	3 months maximum