Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Neil Mehta, MD (ucsf)

Description

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.

Details

Keywords

Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B, Hepatocellular carcinoma surveillance, GALAD, Alpha Fetoprotein, Liver Neoplasms, Hepatocellular Carcinoma, Liver Ultrasound with or without AFP

Eligibility

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94117 United States
  • University of Southern California accepting new patients
    Los Angeles California 90089 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Lead Scientist at University of California Health

  • Neil Mehta, MD (ucsf)
    Dr. Neil Mehta is a gastroenterologist and specialist in liver transplantation. In his research, Mehta examines liver cancer treatment, particularly as related to liver transplants. He has contributed to important publications in this area. His other research interests include outcomes for patients who undergo liver transplantation and cardiac iron overload in patients with chronic liver disease.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Texas Southwestern Medical Center
ID
NCT06084234
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 5500 study participants
Last Updated