University of Texas Southwestern Medical Center
Amit Singal
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.
Carcinoma, Hepatocellular
Liver Cancer
Liver Cirrhosis
Hepatitis B
GALAD
Liver Ultrasound with or without AFP
PHASE4
The TRACER phase IV biomarker study is a randomized trial comparing ultrasound-based screening versus a biomarker-based strategy in patients with cirrhosis. In brief, 5500 patients with cirrhosis from any etiology would be randomized in a 1:1 fashion to Arm A offering semi-annual ultrasound +/- AFP-based screening or Arm B offering semi-annual biomarker-based screening. Randomization will be stratified by site, Child Pugh class (A vs. B), liver disease etiology (viral, non-viral, and non-cirrhotic HBV infection) and sex. Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and reduction in the proportion of late-stage HCC, will be assessed at the end of Year 5.5. If the results are promising, study team will continue extended follow-up and compare the incidence of late-stage HCC between the two arms at Year 8 and reduction in HCC mortality during long term follow up. Study team will include adult patients, age ≥ 18 years, with Child Pugh class A or B cirrhosis of any etiology or non-cirrhotic chronic hepatitis B virus infection with PAGE-B score \>9. Study team will exclude patients post liver transplantation, patients with Child Pugh C cirrhosis, patients with significant comorbidity and limited life expectancy, and those with history of other malignancy, except non-melanoma skin cancer or indolent tumors, within 3 years prior to enrollment given lack of screening recommendations in those patient populations. Study team will also exclude patients with suspicious liver masses at baseline as well as those with a solid lesion ≥1 cm on ultrasound or AFP ≥20 ng/mL without diagnostic evaluation to exclude HCC. Study team will also exclude patients in whom the provider plans to follow the patient with CT or MRI-based surveillance. GALAD is not recommended in patients with pregnancy or active warfarin use given known impact on biomarker performance, so these patients will be excluded. At enrollment, study team will record patient demographics and clinical characteristics using a combination of electronic medical records and patient questionnaires. Patients will then be offered semi-annual surveillance as defined by their study arm: ultrasound and AFP for patients in Arm A and the biomarker, GALAD, for patients in Arm B. Repeat surveillance tests will be offered every six months (per assigned arm) for patients with normal surveillance results. Diagnostic evaluation with multi-phasic CT or contrast-enhanced MRI will be recommended for any patients with abnormal screening results. Patients with normal diagnostic testing (i.e., false positive result) will be recommended to return to their assigned surveillance arm. Standardized criteria from the AASLD and LI-RADS will be used to define incident HCC. Study team will use a set of validated surveys (e.g., Psychological Consequences Questionnaire, Decision Regret scale, FACIT-COST) to measure secondary outcomes of interest including psychological and financial harms.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 5500 participants |
| Masking : | NONE |
| Primary Purpose : | SCREENING |
| Official Title : | National Liver Cancer Screening Trial |
| Actual Study Start Date : | 2023-12-26 |
| Estimated Primary Completion Date : | 2029-12-31 |
| Estimated Study Completion Date : | 2034-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 85 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Southern California
Los Angeles, California, United States, 90089
RECRUITING
Stanford University
Redwood City, California, United States, 94063
RECRUITING
University of California, San Francisco
San Francisco, California, United States, 94117
RECRUITING
Indiana University
Indianapolis, Indiana, United States, 46202
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
RECRUITING
University of Michigan
Ann Arbor, Road cancer, United States, 48109
RECRUITING
Henry Ford Health System
Detroit, Road cancer, United States, 48202
RECRUITING
The University of Minnesota
Minneapolis, Minnesota, United States, 55455
RECRUITING
The Feinstein Institutes, Northwell Health, Inc.
Manhasset, New York, United States, 11030
RECRUITING
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
RECRUITING
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
UT Southwestern Medical Center and Parkland Hospital
Dallas, Texas, United States, 75390
RECRUITING
Baylor College of Medicine
Houston, Texas, United States, 77021
NOT YET RECRUITING
Virginia Commonwealth University
Richmond, Virginia, United States, 23219