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Standard Liver Cancer Screening Techniques Compared to a New Screening Technique for Early Detection of Liver Cancer in People with Liver Cirrhosis or Chronic Hepatitis B Infection, The TRACER Trial
Trial Status: active
This phase IV trial compares standard liver cancer screening techniques (ultrasound and alpha fetoprotein measurement) to a new screening technique that uses patient characteristics and blood markers (GALAD score) for early detection of hepatocellular carcinoma (liver cancer) in people with liver cirrhosis or chronic hepatitis B infection. Hepatocellular carcinoma (HCC) surveillance is recommended by several professional societies and is associated with reduced cancer-related death. Ultrasound imaging with or without testing for a protein called alpha fetoprotein is the current standard of care for liver cancer screening, but can miss liver cancer at an early stage. The GALAD score is a score used to assess risk of developing liver cancer. It is calculated using a person's gender, age, and the values of certain markers in the blood that are currently used for liver cancer risk assessment and screening. The GALAD score screening method may work better than current standard screening methods for the early detection of liver cancer in people with cirrhosis or chronic hepatitis B infection.
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 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/mm^3 within 60 days prior to consent
Known pregnancy at consent
Active warfarin use
Additional locations may be listed on ClinicalTrials.gov for NCT06084234.
I. To compare effectiveness of offering ultrasound (US) with or without (+/-) alpha fetoprotein (AFP) versus (vs.) GALAD-based surveillance to reduce late-stage HCC at diagnosis.
SECONDARY OBJECTIVES:
I. To compare screening utilization of offering US +/- AFP vs. GALAD-based surveillance.
II. To evaluate effectiveness of offering US +/- AFP vs. GALAD-based surveillance, as measured by proportion of HCC detected at a late stage (defined as HCC beyond Barcelona Clinic Liver Cancer [BCLC] stage A), incidence of late-stage HCC (using Milan Criteria and BCLC criterion), and curative therapy receipt.
III. To evaluate safety of offering US +/- AFP vs. GALAD-based surveillance, as measured by screening-related physical, financial, and psychological harms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo liver US +/- blood sample collection for AFP measurement per standard of care every 6 months. Patients with abnormal results may undergo computed tomography (CT) or magnetic resonance imaging (MRI) at the discretion of their clinical provider.
ARM B: Patients undergo blood sample collection for GALAD testing every 6 months. Patients with abnormal GALAD results may undergo CT or MRI on study.
After completion of study intervention, patients are followed up yearly for up to 20 years.
Trial PhasePhase IV
Trial Typescreening
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
