Compares two screening methods for liver cancer in people with cirrhosis or hepatitis B
Compares ultrasound and blood tests for liver cancer screening in people with liver disease.
Plain-language title generated from the registry record
Registry title: National Liver Cancer Screening Trial
Key facts
- Where
- Ann Arbor, Boston, Chapel Hill, Chicago, Cleveland, Dallas, Detroit, Houston, Indianapolis, Los Angeles, Manhasset, Minneapolis, Philadelphia, Redwood City, Richmond, Roseville, and San Francisco, United StatesSee the 19 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06084234, who can take part
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- University of North CarolinaChapel Hill, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- The Cleveland ClinicCleveland, United StatesTaking people
- Case Western Reserve UniversityCleveland, United StatesNo longer taking part
- UT Southwestern Medical Center and Parkland HospitalDallas, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Indiana UniversityIndianapolis, United StatesTaking people
- University of Southern CaliforniaLos Angeles, United StatesTaking people
- The Feinstein Institutes, Northwell Health, Inc.Manhasset, United StatesTaking people
- Hennepin HealthcareMinneapolis, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Stanford UniversityRedwood City, United StatesTaking people
- Virginia Commonwealth UniversityRichmond, United StatesTaking people
- Kaiser PermanenteRoseville, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Texas Southwestern Medical Center
- Trial code
- NCT06084234
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
National Liver Cancer Screening Trial
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.
Inclusion: 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: 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; Actively listed for liver transplantation; Diagnosis of alcohol-associated hepatitis within 3 months prior to consent; 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); History of a transjugular intrahepatic portosystemic shunt (TIPS); History of Fontan associated liver disease or cardiac cirrhosis; History of solid organ transplantation; Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis); In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent; Patient will be excluded for any of the following exclusion criteria:; Child Pugh C cirrhosis; History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma; Patient's provider is planning to use MRI- or CT- based surveillance moving forward; Known pregnancy at consent; Active warfarin use.