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Routine blood test could spot silent liver disease

NCT ID NCT05880173

Diagnosis Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This study is testing whether a common blood test, called FIB4, can help find people with advanced liver fibrosis (serious liver scarring) who don't know they have it. About 500 adults aged 18-70 with a high FIB4 result will get a more detailed liver check, including a special ultrasound and possibly a biopsy. The goal is to see if this screening approach works well enough to become a standard early detection tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FIB4 blood test and FibroScan
What this could lead to
If successful, this could lead to a simple, routine blood test to catch serious liver scarring early in people who don't know they have it.
What could go wrong
This is an early screening study, not a treatment trial. The blood test may produce false positives or miss some cases, and the results need further validation before widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

391 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fibrotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced liver fibrosis Screening

Contacts and locations

Locations

  • Centre Hospitalier de Lens

    Lens, France

  • Chu Angers

    Angers, 49000, France

  • Chu Bordeaux

    Angers, 49000, France

  • Chu Grenoble Alpes

    Grenoble, France

  • Chu Nancy

    Nancy, France

  • Hopital Saint Joseph

    Marseille, France

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