National Liver Cancer Screening Trial

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

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Pennsylvania

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Amit Singal, MD, MS · University of Texas Southwestern Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-26

Primary Completion

2029-12-31

Completion

2034-12-31

FDA Device

Yes

Countries

• United States

Study Locations