Status:
RECRUITING
National Liver Cancer Screening Trial
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Pennsylvania
Conditions:
Carcinoma, Hepatocellular
Liver Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 pati...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patient must meet all of the following inclusion criteria:
- 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
Exclusion
- Patient will be excluded for any of the following exclusion criteria:
- 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
- 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)
- In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
- Known pregnancy at consent
- Active warfarin use
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2034
Estimated Enrollment :
5500 Patients enrolled
Trial Details
Trial ID
NCT06084234
Start Date
December 26 2023
End Date
December 31 2034
Last Update
November 26 2025
Active Locations (18)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
Stanford University
Redwood City, California, United States, 94063
3
Kaiser Permanente
Roseville, California, United States, 95661
4
University of California, San Francisco
San Francisco, California, United States, 94117