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National Liver Cancer Screening Trial
Sponsor: University of Texas Southwestern Medical Center
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.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
5500
Start Date
2023-12-26
Completion Date
2034-12-31
Last Updated
2025-11-26
Healthy Volunteers
No
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.
Locations (18)
University of Southern California
Los Angeles, California, United States
Stanford University
Redwood City, California, United States
Kaiser Permanente
Roseville, California, United States
University of California, San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin Healthcare
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Feinstein Institutes, Northwell Health, Inc.
Manhasset, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center and Parkland Hospital
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States