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Blood test could outshine ultrasound in liver cancer screening

NCT ID NCT06084234

Diagnosis Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This phase IV trial will enroll 5,500 people with liver cirrhosis or chronic hepatitis B—conditions that raise liver cancer risk. Participants are randomly assigned to either standard ultrasound screening or a new blood test called GALAD, which measures three proteins. The goal is to see which method catches more liver cancers at an early, treatable stage. Results are expected after about 5.5 years.

What this could mean

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

Active substance
GALAD biomarker panel (blood test) and liver ultrasound with or without AFP blood test
What this could lead to
If successful, this could show that a simple blood test (GALAD) is better than ultrasound at catching liver cancer early, potentially saving lives through earlier treatment.
What could go wrong
This is a large, long-term trial, so results won't be available for years. The blood test might not outperform ultrasound, or it could lead to more false alarms and unnecessary procedures.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 5,500 people

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

Started

Dec 2023

Expected to finish

Dec 2034

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 to 85 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: Patient must meet all of the following inclusion criteria: 1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment 2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator 3. Able to provide informed consent 4. Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator Exclusion Criteria: Patient will be excluded for any of the following exclusion criteria: 1. Child Pugh C cirrhosis 2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma 3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature) 4. AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions 5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent 6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent 7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent 8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward 9. History of a transjugular intrahepatic portosystemic shunt (TIPS) 10. History of Fontan associated liver disease or cardiac cirrhosis 11. History of solid organ transplantation 12. Actively listed for liver transplantation 13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent 14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis) 15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent 16. Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples) 17. In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent 18. Known pregnancy at consent 19. Active warfarin use

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatitis B virus infection liver cancer Liver Neoplasms hepatocellular carcinoma prevention target

As listed by the trial registrant

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

Carcinoma, hepatocellular Hepatitis B Liver cancer Liver cirrhosis

How to take part

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

  1. The places running it

    19 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

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77021, United States

  • Case Western Reserve University

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Hennepin Healthcare

    RECRUITING

    Minneapolis, Minnesota, 55415, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Kaiser Permanente

    RECRUITING

    Roseville, California, 95661, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063, United States

  • The Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Feinstein Institutes, Northwell Health, Inc.

    RECRUITING

    Manhasset, New York, 11030, United States

  • UT Southwestern Medical Center and Parkland Hospital

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94117, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90089, United States

  • Virginia Commonwealth University

    NOT_YET_RECRUITING

    Richmond, Virginia, 23219, United States

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