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RECRUITING
NCT06084234
PHASE4

National Liver Cancer Screening Trial

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

GALAD

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

DIAGNOSTIC_TEST

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