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Simple blood test could spot silent liver damage early

NCT ID NCT06119997

Knowledge-focused Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a two-step screening method to find advanced liver fibrosis in people who don't yet have symptoms. First, a routine blood test calculates a score called FIB-4. If that score is high, patients get a more specialized non-invasive test. The goal is to see how well this approach works in primary care settings. About 500 adults aged 18–70 with no known hepatitis C infection will take part.

What this could mean

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

What this could lead to
If successful, this screening approach could help detect advanced liver fibrosis earlier in people without symptoms, potentially preventing progression to cirrhosis.
What could go wrong
This is an observational study, not a treatment trial. It only tests the screening process, so it won't directly improve health. The results may not apply to all populations.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Study Population (FIB-4 ≥2.67): The expected frequency of advanced fibrosis in the study population (= positive predictive value) is estimated at 14%, based on literature data (sensitivity and specificity of FIB-4 ≥2.67 for the diagnosis of advanced fibrosis at 32% and 96%, prevalence of advanced fibrosis at 2% in the screened population (10)). Assuming adherence to recommendations to achieve a 10% diagnosed liver fibrosis, corresponding to a non-inferiority margin of 4% compared to the theoretical percentage of 14%, 441 patients are required (power at 80%, alpha risk at 5%, binomial test for a single sample). This sample size will be extended to 500 patients with FIB-4 ≥2.67, taking potential attrition into account.

Ages

18 to 70 years

Sex

Anyone

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: * Patients between 18 and 70 years of age * FIB-4 2.67 * Patients covered by Health Insurance System Exclusion Criteria: * Prescription triggering FIB-4 emanate from a hepatogastroenterologist or oncologist * Conditions associated with high risk false-positive FIB-4: ASAT or ALAT \> 300 IU/L, platelets \<50 G/L or \>500 G/L. * Patient refusing to participate * Subjects under guardianship or deprived of liberty

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fibrotic liver disease

As listed by the trial registrant

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

Hepatic fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Grenoble Alpes

    RECRUITING

    Grenoble, France

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