National Liver Cancer Screening Trial
University of Texas Southwestern Medical Center
5,500 participants
Dec 26, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria19
- 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
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.
Locations(18)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06084234