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AI and blood biomarkers could catch hidden liver damage

NCT ID NCT06888310

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study tests whether combining artificial intelligence with blood biomarkers can improve the detection of compensated advanced chronic liver disease (cACLD) in people with fatty liver disease. Researchers will enroll 408 adults with dysmetabolic liver disease and compare standard diagnostic methods with an AI-enhanced approach that includes extra blood sampling. The goal is to find a more accurate, noninvasive way to identify those at risk of progression, potentially reducing the need for liver biopsies.

What this could mean

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

Active substance
extra blood sampling to search for biomarkers
What this could lead to
If successful, this could lead to a simple blood test that helps doctors spot advanced liver disease earlier and more accurately, potentially reducing the need for invasive biopsies.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The biomarkers may not prove accurate enough in larger or more diverse groups, and the AI model may not work as well outside this specific hospital setting.

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 408 people

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

Started

Dec 2024

Expected to finish

Mar 2027

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.

Ages

18 years and older

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\>=18; sex (M,F); * dysmetabolic liver disease according new nomenclature definition; * suspicion of cACLD by LSM\>=10 with VCTE; * routine esogastroduodenoscopy report within 12 months of VCTE for identification of high-risk varices (HRV). Exclusion Criteria: * portal vein thrombosis, * infiltrative liver neoplasms, and conditions are known for their potential influence on the LSM results (congestive liver disease, extrahepatic biliary obstruction, ALT \> 5x upper normal limit).

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

NAFLD NASH

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Medicina Interna e Trapianto di Fegato

    Roma, Roma, 00168, Italy

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