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.
Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B
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.
National Liver Cancer Screening Trial
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University of Southern California, Los Angeles, California, United States, 90089
University of California, San Francisco, San Francisco, California, United States, 94117
Indiana University, Indianapolis, Indiana, United States, 46202
Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
University of Michigan, Ann Arbor, Michigan, United States, 48109
Henry Ford Health System, Detroit, Michigan, United States, 48202
The Feinstein Institutes, Northwell Health, Inc., Manhasset, New York, United States, 11030
University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104
UT Southwestern Medical Center and Parkland Hospital, Dallas, Texas, United States, 75390
Baylor College of Medicine, Houston, Texas, United States, 77021
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 85 Years
ALL
No
University of Texas Southwestern Medical Center,
Amit Singal, MD, MS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center
2034-12-31