National Liver Cancer Screening Trial
Recruiting · NCT06084234 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
GALADLiver Ultrasound with or without AFP
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patient must meet all of the following inclusion criteria:
- 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
- Patient is eligible for HCC surveillance according to treating physician or by the site investigator
- Able to provide informed consent
- 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:
- Child Pugh C cirrhosis
- History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
- 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)
- 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
- Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
- History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
- 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
- Patient's provider is planning to use MRI- or CT- based surveillance moving forward
- History of a transjugular intrahepatic portosystemic shunt (TIPS)
- History of Fontan associated liver disease or cardiac cirrhosis
- History of solid organ transplantation
- Actively listed for liver transplantation
- Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
- Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
- In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
- Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
- In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
- Known pregnancy at consent
- Active warfarin use
Where it is running
19 locations listed across 12 US states.
- University of Southern California - Los Angeles, California, United States
- Stanford University - Redwood City, California, United States
- Kaiser Permanente - Roseville, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Northwestern University - Chicago, Illinois, United States
- Indiana University - Indianapolis, Indiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Hennepin Healthcare - Minneapolis, Minnesota, United States
- University of Minnesota - Minneapolis, Minnesota, United States
- The Feinstein Institutes, Northwell Health, Inc. - Manhasset, New York, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Case Western Reserve University - Cleveland, Ohio, United States
- The Cleveland Clinic - Cleveland, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- UT Southwestern Medical Center and Parkland Hospital - Dallas, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- Virginia Commonwealth University - Richmond, Virginia, United States