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RECRUITINGPhase 4INTERVENTIONAL

National Liver Cancer Screening Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: Patient must meet all of the following Who May Qualify: 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 willing to sign a consent form 4. Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator Who Should NOT Join This Trial: Patient will be excluded for any of the following Who Should NOT Join This Trial: 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 8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward 9. History of a transjugular intrahepatic portosystemic shunt (TIPS) 10. History of Fontan associated liver disease or cardiac cirrhosis 11. History of solid organ transplantation 12. Actively listed for liver transplantation 13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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 Exclusion Criteria: 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 8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward 9. History of a transjugular intrahepatic portosystemic shunt (TIPS) 10. History of Fontan associated liver disease or cardiac cirrhosis 11. History of solid organ transplantation 12. Actively listed for liver transplantation 13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent 14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis) 15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent 16. 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) 17. In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent 18. Known pregnancy at consent 19. Active warfarin use

Treatments Being Tested

DIAGNOSTIC_TEST

GALAD

GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.

DIAGNOSTIC_TEST

Liver Ultrasound with or without AFP

This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.

Locations (18)

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
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