At a glance
ClinicalIndex Comparison Record- ✓Age 18-85 with cirrhosis from any etiology or chronic hepatitis B with PAGE-B score >9 within 12 months
- ✓Eligible for HCC surveillance per treating physician or investigator
- ✓Able to provide informed consent
- ✓Life expectancy >6 months after consent
- ✕Child-Pugh C cirrhosis
- ✕History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
- ✕Solid nodule ≥1cm on baseline ultrasound within 9 months without benign confirmation on CT/MRI
- ✕AFP >20 ng/mL within 6 months without imaging showing lack of suspicious lesions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
National Liver Cancer Screening Trial
In Brief
A Phase 4 clinical trial evaluating GALAD and Liver Ultrasound with or without AFP for Carcinoma, Hepatocellular and 3 related conditions. Currently recruiting, targeting 5,500 participants across 18 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.
This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.