National Liver Cancer Screening Trial

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.

NCT Number	NCT06084234
Lead Sponsor	University of Texas Southwestern Medical Center Collaborators: National Cancer Institute (NCI), University of Pennsylvania, University of Michigan, Dana-Farber Cancer Institute, Baylor College of Medicine, Fred Hutchinson Cancer Center, The Cleveland Clinic
Conditions	Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B
Enrollment	5,500 participants
Start Date	2023-12-26
Primary Completion	2029-12-31 (estimated)
Study Completion	2034-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12