NCT05880173

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2023Mar 2027

First Submitted

Initial submission to the registry

January 6, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3.4 years

First QC Date

January 6, 2023

Last Update Submit

December 1, 2025

Conditions

ScreeningAdvanced Liver Fibrosis

Keywords

Screeningadvanced liver fibrosisnon-invasive tests

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Determine the rate of patients requiring second-line evaluation by elastometry

    3 months maximum

  • Determine the rate of patients requiring management by a liver disease specialist.

    3 months maximum

  • Determine the average cost spent on a patient diagnosed with advanced liver fibrosis

    3 months maximum

  • Determine patient adherence to the screening procedure

    3 months maximum

  • Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority

    3 months maximum

  • +1 more secondary outcomes

Study Arms (1)

Diagnostic FIB4

OTHER

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

Diagnostic Test: FIB4

Interventions

FIB4DIAGNOSTIC_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

Diagnostic FIB4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chu Angers

Angers, 49000, France

NOT YET RECRUITING

Chu Bordeaux

Angers, 49000, France

NOT YET RECRUITING

Chu Grenoble Alpes

Grenoble, France

RECRUITING

Centre Hospitalier de Lens

Lens, France

RECRUITING

Hopital Saint Joseph

Marseille, France

NOT YET RECRUITING

Chu Nancy

Nancy, France

RECRUITING

Central Study Contacts

Clémence CANIVET, MD, PHD

CONTACT

(0)241353142clemence.canivet@chu-angers.fr

Matthieu LE LAY

CONTACT

(0)241355891matthieu.lelay@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

May 30, 2023

Study Start

October 20, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)