Actively Recruiting
National Liver Cancer Screening Trial
Led by University of Texas Southwestern Medical Center · Updated on 2025-11-26
5500
Participants Needed
18
Research Sites
574 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
National Liver Cancer Screening Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years with cirrhosis from any cause or chronic hepatitis B with PAGE-B score over 9 within 12 months
- Eligible for liver cancer screening as determined by doctor or site investigator
- Able to give informed consent
- Expected to live longer than 6 months as judged by doctor or investigator
You will not qualify if you...
- Child Pugh class C cirrhosis
- History or symptoms of liver or bile duct cancer
- Solid liver nodule 1 cm or larger on ultrasound within 9 months without follow-up CT/MRI showing it is benign
- AFP level over 20 ng/mL within 6 months without CT or MRI excluding suspicious lesions
- Recent diagnosis of certain liver imaging results (LR-3 ≥1 cm, LR-4, LR-5, LR-M) within 6 months
- Active cancer other than non-melanoma skin cancer or slow-growing cancers under surveillance within 2 years
- Planned use of CT or MRI for liver cancer surveillance
- History of liver shunt procedure (TIPS), Fontan liver disease, cardiac cirrhosis, or solid organ transplant
- Currently listed for liver transplant
- Alcohol-associated hepatitis diagnosed within 3 months
- Signs of acute Wilson disease
- Recent active cholangitis in patients with primary sclerosing cholangitis
- Known habitual non-adherence to medical procedures or research
- For HIV patients, CD4 count below 100 cells/mm3 within 60 days
- Known pregnancy at consent
- Current use of warfarin medication
AI-Screening
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Trial Site Locations
Total: 18 locations
1
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
2
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
3
Kaiser Permanente
Roseville, California, United States, 95661
Actively Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94117
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Hennepin Healthcare
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
11
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
The Feinstein Institutes, Northwell Health, Inc.
Manhasset, New York, United States, 11030
Actively Recruiting
13
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
14
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
15
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
UT Southwestern Medical Center and Parkland Hospital
Dallas, Texas, United States, 75390
Actively Recruiting
17
Baylor College of Medicine
Houston, Texas, United States, 77021
Actively Recruiting
18
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Not Yet Recruiting
Research Team
A
Amit Singal, MD, MS
CONTACT
S
Sneha Deodhar, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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