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New study aims to spare thousands from painful liver biopsies

NCT ID NCT04681573

Diagnosis Sponsor: University Hospital, Angers 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two step-by-step approaches to diagnose advanced liver fibrosis in people with NAFLD (fatty liver disease). Both methods start with a simple blood test, then use a more advanced test only if needed, aiming to avoid invasive liver biopsies. About 1,045 participants will be enrolled to see which strategy is more accurate and practical for 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

About 1,045 people

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

Started

Apr 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

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 80 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: 1. Presence of NAFLD as defined by : * The presence of liver steatosis as assessed by ultrasonography (bright liver) or magnetic resonance imaging/spectroscopy (fat fraction \>5.6%) or Controlled Attenuation Parameter (≥248 dB/m) * The absence of steatosis-inducing drugs (systemic corticosteroids, methotrexate, amiodarone, tamoxifen) * The absence of excessive alcohol consumption (\<210 g/week in men or \<140 g/week in women) * The absence of other causes of chronic liver disease (chronic viral hepatitis B or C, hemochromatosis, auto-immune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease alpha-1-antitrypsin deficiency). 2. Age ≥18 years and ≤80 years 3. Affiliated person or beneficiary of a social security regime 4. Written informed consent of the patient who agree to comply with the study protocol. Exclusion Criteria: 1. Decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, liver failure, hepato-renal syndrome) 2. Hepatocellular carcinoma 3. Inability to safely undergo liver biopsy 4. Participation in other intervention study with drug protocol treatment in progress at the time of inclusion or within one month prior to inclusion in the study. 5. Pregnant, breastfeeding or parturient woman 6. Person restricted by judicial or administrative decision 7. Person under psychiatric care under restraint 8. Person subject to a legal protection measure 9. Person unable to express consent

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Conditions

The condition(s) this trial relates to.

disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

NAFLD

How to take part

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

  1. The places running it

    12 sites. 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

  • Avicenne Hospital (Greater Paris University Hospitals)

    NOT_YET_RECRUITING

    Bobigny, France

  • Cochin Hospital

    NOT_YET_RECRUITING

    Paris, France

  • Departemental Hospital Center of Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • Edouard Herriot Hospital

    NOT_YET_RECRUITING

    Lyon, France

  • La Croix Rousse Hospital

    RECRUITING

    Lyon, France

  • La Pitié Salpétrière Hospital (Greater Paris University Hospitals)

    NOT_YET_RECRUITING

    Paris, France

  • Saint Joseph Hospital

    NOT_YET_RECRUITING

    Marseille, France

  • Saint-Antoine Hospital (Greater Paris University Hospitals)

    ACTIVE_NOT_RECRUITING

    Paris, France

  • University Hospital of Angers

    RECRUITING

    Angers, France

  • University Hospital of Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • University Hospital of Bordeaux

    ACTIVE_NOT_RECRUITING

    Pessac, France

  • University Hospital of Dijon

    RECRUITING

    Dijon, France

  • University Hospital of Grenoble

    ACTIVE_NOT_RECRUITING

    La Tronche, France

  • University Hospital of Lille

    ACTIVE_NOT_RECRUITING

    Lille, France

  • University Hospital of Limoges

    ACTIVE_NOT_RECRUITING

    Limoges, France

  • University Hospital of Montpellier

    RECRUITING

    Montpellier, France

  • University Hospital of Nancy

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, France

  • University Hospital of Nantes

    ACTIVE_NOT_RECRUITING

    Nantes, France

  • University Hospital of Rennes

    ACTIVE_NOT_RECRUITING

    Rennes, France

  • University Hospital of Tours

    ACTIVE_NOT_RECRUITING

    Tours, France

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