National Liver Cancer Screening Trial

Recruiting now · Phase 4

Conditions studied: Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B

In brief

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.

Key facts

Study ID: NCT06084234
Run by: University of Texas Southwestern Medical Center
People needed: 5500
Starts: 2023-12-26
Expected to finish: 2034-12-31
Last updated by the study team: 2025-11-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient must meet all of the following inclusion criteria:
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
Patient is eligible for HCC surveillance according to treating physician or by the site investigator
Able to provide informed consent
Life expectancy >6 months (after consent) as determined by the treating provider or site investigator

You may not qualify if…

Patient will be excluded for any of the following exclusion criteria:
Child Pugh C cirrhosis
History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
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)
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
Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
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
Patient's provider is planning to use MRI- or CT- based surveillance moving forward
History of a transjugular intrahepatic portosystemic shunt (TIPS)
History of Fontan associated liver disease or cardiac cirrhosis
History of solid organ transplantation
Actively listed for liver transplantation
Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
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)
In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
Known pregnancy at consent
Active warfarin use

Where it is running

University of Southern California — Los Angeles, California, United States (enrolling)
Stanford University — Redwood City, California, United States (enrolling)
Kaiser Permanente — Roseville, California, United States (enrolling)
University of California, San Francisco — San Francisco, California, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
Indiana University — Indianapolis, Indiana, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Henry Ford Health System — Detroit, Michigan, United States (enrolling)
Hennepin Healthcare — Minneapolis, Minnesota, United States (enrolling)
University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
The Feinstein Institutes, Northwell Health, Inc. — Manhasset, New York, United States (enrolling)
University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
UT Southwestern Medical Center and Parkland Hospital — Dallas, Texas, United States (enrolling)
Baylor College of Medicine — Houston, Texas, United States (enrolling)
Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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