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National Liver Cancer Screening Trial (TRACER)

Primary Investigator
Parikh, Neehar
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT06084234
UM Number
00239744
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Biomarker Development and Validation
ID (Protocol)
61732
Secondary Protocol No
HUM00239744
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Liver
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.

Eligibility: Inclusion Criteria
  •   Patient must meet all of the following inclusion criteria:
  •   1. 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
  •   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
  •   Patient will be excluded for any of the following exclusion criteria:
  •   1. Child Pugh C cirrhosis
  •   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