Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
5500 participants
INTERVENTIONAL
2023-12-26
2034-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm A: Semi-annual surveillance using liver ultrasound +/- alpha-fetoprotein
Participants in this arm will undergo current standard of care surveillance procedures i.e. liver ultrasound with or without alpha fetoprotein (AFP) measurement.
Liver Ultrasound with or without AFP
This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.
Arm B: Semi-annual surveillance using GALAD
For participants in this arm, study team will order GALAD measurement every 6 months +/- 3 months.
GALAD
GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.
Interventions
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GALAD
GALAD is a 3 biomarker panel incorporating AFP, AFP-L3% and DCP (all FDA approved), with patient age and sex.
Liver Ultrasound with or without AFP
This intervention consists of current standard of care ultrasound based surveillance with or without alpha-fetoprotein measurement.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pennsylvania
OTHER
University of Michigan
OTHER
Dana-Farber Cancer Institute
OTHER
Baylor College of Medicine
OTHER
Fred Hutchinson Cancer Center
OTHER
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Amit Singal
Professor
Principal Investigators
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Amit Singal, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kali Zhou, MD
Role: primary
Role: backup
References
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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.
Other Identifiers
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TRACER
Identifier Type: -
Identifier Source: org_study_id
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