National Liver Cancer Screening Trial
TRACER
2 other identifiers
interventional
5,500
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2023
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedStudy Start
First participant enrolled
December 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2034
November 26, 2025
November 1, 2025
6 years
October 10, 2023
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of HCC detected at late stage
Proportion of HCC detected at a late stage, defined as HCC beyond Milan Criteria (one tumor less than or equal to 5 cm or 2-3 tumors each less than or equal to 3 cm, in the absence of vascular invasion or extra-hepatic metastases)
5.5 years
Secondary Outcomes (7)
HCC Screening utilization
5.5 years
Proportion of HCC detected at a late-stage (defined based on BCLC stage)
5.5 years
Incidence of late-stage HCC
8 years
Proportion of HCC cases that receive Curative therapy
5.5 years
Number of participants who encountered screening related physical harm
5.5 years
- +2 more secondary outcomes
Study Arms (2)
Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein
ACTIVE COMPARATORParticipants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.
Arm B: Semi-annual surveillance using GALAD
EXPERIMENTALFor participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- National Cancer Institute (NCI)collaborator
- University of Pennsylvaniacollaborator
- University of Michigancollaborator
- Dana-Farber Cancer Institutecollaborator
- Baylor College of Medicinecollaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (18)
University of Southern California
Los Angeles, California, 90089, United States
Stanford University
Redwood City, California, 94063, United States
Kaiser Permanente
Roseville, California, 95661, United States
University of California, San Francisco
San Francisco, California, 94117, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
The Feinstein Institutes, Northwell Health, Inc.
Manhasset, New York, 11030, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UT Southwestern Medical Center and Parkland Hospital
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77021, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Related Publications (1)
Singal AG, Parikh ND, Kanwal F, Marrero JA, Deodhar S, Page-Lester S, Lopez C, Feng Z, Tayob N. National Liver Cancer Screening Trial (TRACER) study protocol. Hepatol Commun. 2024 Nov 4;8(11):e0565. doi: 10.1097/HC9.0000000000000565. eCollection 2024 Nov 1.
PMID: 39495136DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Singal, MD, MS
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2023
First Posted
October 16, 2023
Study Start
December 26, 2023
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2034
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share