National Liver Cancer Screening Trial
University of Texas Southwestern Medical Center
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.
Description
The TRACER phase IV biomarker study is a randomized trial comparing ultrasound-based screening versus a biomarker-based strategy in patients with cirrhosis. In brief, 5500 patients with cirrhosis from any etiology would be randomized in a 1:1 fashion to Arm A offering semi-annual ultrasound +/- AFP-based screening or Arm B offering semi-annual biomarker-based screening. Randomization will be stratified by site, Child Pugh class (A vs. B), liver disease etiology (viral, non-viral, and non-cirrhotic HBV infection) and sex. Patients will be recruited from 15 sites (mix of tertiary care and large…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patient must meet all of the following inclusion criteria: 1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment 2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator 3. Able to provide informed consent 4. Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator Exclusion Criteria: Patient will be excluded for any of the following exclusion criteria: 1. Child Pugh C cirrhosi…
Interventions
- Diagnostic TestGALAD
GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.
- Diagnostic TestLiver 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 CaliforniaLos Angeles, California
- Stanford UniversityRedwood City, California
- Kaiser PermanenteRoseville, California
- University of California, San FranciscoSan Francisco, California
- Northwestern UniversityChicago, Illinois
- Indiana UniversityIndianapolis, Indiana