Sponsor
University of Texas Southwestern Medical Center
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT06084234
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.
Intervention
GALAD, Liver Ultrasound with or without AFP
Condition
Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B
Investigators
Amit Singal, MD, MS, Kali Zhou, MD, Sanjaya Satapathy, MBBS, MS, Neil Mehta, MD, Fasiha Kanwal, MD, MSHS, Irun Bhan, MD, Reena Salgia, MD, Sara Fares, Sneha Deodhar, MS, Jorge Marrero, MD,MS, Neehar Parikh, MD, MS, Naga Chalasani, MD, Jessica Peruski, Grace Kim, Rae Davis, Sherri Cummins, Shay Robison, Dibnain Nanda, , Megan Michta