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Comparing ultrasound and biomarker screening for liver cancer in patients with cirrhosis or hepatitis B

National Liver Cancer Screening Trial

Phase 4 Interventional University of Texas Southwestern Medical Center · NCT06084234

This study is testing whether ultrasound or a blood test is better at finding liver cancer early in people with cirrhosis or chronic hepatitis B.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment5500 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorUniversity of Texas Southwestern Medical Center Academic / other
Locations18 sites (Los Angeles, California and 17 other locations)
Trial IDNCT06084234 on ClinicalTrials.gov

What this trial studies

The National Liver Cancer Screening Trial is an adaptive randomized phase IV trial that aims to compare the effectiveness of ultrasound-based screening versus biomarker-based screening in 5,500 patients with cirrhosis or chronic hepatitis B. Participants will be randomly assigned to either semi-annual ultrasound and AFP-based screening or semi-annual GALAD biomarker screening. The trial will stratify randomization by factors such as sex, enrolling site, Child Pugh class, and HCC etiology. The primary goal is to assess the reduction in late-stage hepatocellular carcinoma (HCC) over a follow-up period of 5.5 years.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-85 with Child Pugh class A or B cirrhosis or chronic hepatitis B with a PAGE-B score greater than 9.

Not a fit: Patients with Child Pugh C cirrhosis, those who have undergone liver transplantation, or individuals with significant comorbidities and limited life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved early detection of liver cancer, potentially reducing the incidence of late-stage disease and improving patient outcomes.

How similar studies have performed: Previous studies have shown promise in using biomarker-based screening for liver cancer, but this specific comparison of ultrasound versus GALAD is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Los Angeles, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, HepatocellularLiver CancerLiver CirrhosisHepatitis BHepatocellular carcinoma surveillanceGALADAlpha Fetoprotein
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.