Comparing ultrasound and biomarker screening for liver cancer in patients with cirrhosis or hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The National Liver Cancer Screening Trial is an adaptive randomized phase IV trial that aims to compare the effectiveness of ultrasound-based screening versus biomarker-based screening in 5,500 patients with cirrhosis or chronic hepatitis B. Participants will be randomly assigned to either semi-annual ultrasound and AFP-based screening or semi-annual GALAD biomarker screening. The trial will stratify randomization by factors such as sex, enrolling site, Child Pugh class, and HCC etiology. The primary goal is to assess the reduction in late-stage hepatocellular carcinoma (HCC) over a follow-up period of 5.5 years.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Stanford University
  Redwood City, California, United States Recruiting
• Kaiser Permanente
  Roseville, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Amit Singal, MD, MS — University of Texas Southwestern Medical Center
• Study coordinator: Amit Singal, MD, MS
• Email: Amit.Singal@UTSouthwestern.edu
• Phone: 214-645-8821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.