RecruitingCarcinoma, HepatocellularLiver CancerLiver Cirrhosis

National Liver Cancer Screening Trial

Eligible age

18–85 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

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.

Sponsor: University of Texas Southwestern Medical Center

You may qualify if…

✓ 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

You may not qualify if…

✕ Patient will be excluded for any of the following exclusion criteria:
✕ 1. Child Pugh C cirrhosis
✕ 2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
✕ 3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
✕ 4. AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
✕ 5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
✕ 6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
✕ 7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent