National Liver Cancer Screening Trial

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Oct 10, 2023

Keywords

ClinConnect Summary

The National Liver Cancer Screening Trial is a research study that aims to find out which method of screening is better for detecting liver cancer in patients with certain liver conditions. Specifically, the trial is comparing two approaches: one that uses ultrasound and a blood test called AFP, and another that relies solely on a different blood test called GALAD. The study will include about 5,500 patients who either have cirrhosis (a serious liver condition) from any cause or chronic hepatitis B infection. To participate, patients need to be between 18 and 85 years old, have a specific score indicating their liver condition, and be able to provide informed consent.

Patients will be randomly assigned to one of the two screening methods and will have screenings every six months for about five and a half years. The main goal of the trial is to see if these screenings can reduce the number of patients diagnosed with late-stage liver cancer. Participants can expect regular check-ups and monitoring while contributing to important research that could improve liver cancer detection in the future. It's important to note that some patients may not be eligible to join due to certain health conditions.

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Eligibility criteria

• 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