Recruiting

Liver Cancer Screening

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06084234

Conditions

Carcinoma, Hepatocellular

Liver Cancer

Liver Cirrhosis

Hepatitis B

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

GALAD

Liver Ultrasound with or without AFP

Study Details

Brief summary:

The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.

Conditions

Carcinoma, Hepatocellular

Liver Cancer

Liver Cirrhosis

Hepatitis B

Study ID

NCT06084234

Start date

Dec 26, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein

Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.

experimental: Arm B: Semi-annual surveillance using GALAD

For participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.

Interventions

GALAD

GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.

Liver Ultrasound with or without AFP

This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.

Primary outcome measure

  • Proportion of HCC detected at late stage [ Time Frame: 5.5 years ]

Central Contacts and Locations

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Principal Investigator:

Kali Zhou, MD

Stanford University

Recruiting

Redwood City, California, United States, 94063

Contacts

Principal Investigator:

Paul Kwo, MD

Kaiser Permanente

Recruiting

Roseville, California, United States, 95661

Contacts

Principal Investigator:

Sreepriya Balasubramanian, MD, MPH

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94117

Contacts

Principal Investigator:

Neil Mehta, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Laura Kulik, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sherri Cummins

shcummin@iu.edu

Principal Investigator:

Naga Chalasani, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Irun Bhan, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Neehar Parikh, MD, MS

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Jessica Peruski

jperusk1@hfhs.org

Principal Investigator:

Reena Salgia, MD

Hennepin Healthcare

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

Jose Debes, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator:

Elizabeth Aby, MD

The Feinstein Institutes, Northwell Health, Inc.

Recruiting

Manhasset, New York, United States, 11030

Contacts

Principal Investigator:

Sanjaya Satapathy, MBBS, MS

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Andrew Moon, MD

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Pierre Gholam, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Jorge Marrero, MD,MS

UT Southwestern Medical Center and Parkland Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Amit Singal, MD, MS

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77021

Contacts

Principal Investigator:

Fasiha Kanwal, MD, MSHS

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Hepatocellular carcinoma surveillance
  • GALAD
  • Alpha Fetoprotein

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-12.