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Blood test may spare unneeded liver biopsies for fatty liver patients

NCT ID NCT05370053

Diagnosis Sponsor: University of Kansas Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving doctors the results of a blood test called ELF helps them better diagnose advanced liver scarring (fibrosis) in people with fatty liver disease. About 450 patients were randomly assigned to have the ELF test or not during their liver clinic visit. The goal was to see if the test leads to more accurate diagnoses and fewer unnecessary liver biopsies.

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

450 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2022

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: * Patients from hepatology clinic undergoing new evaluation for NAFLD. Exclusion Criteria: * Patients with liver biopsy within the last five years or decompensated cirrhosis were excluded. Patients known to have other liver diseases were also excluded. Patients consuming \> 14 drinks in the past 6 months were excluded. Patients may be subsequently found to have positive viral or autoimmune serologies after enrollment because the serology result is typically not available at the time of enrollment. These patients will be excluded from the analysis.

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Fatty liver NAFLD

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.