Lexington, Mass.– A major national study backed by the National Cancer Institute is evaluating a promising new blood-based algorithm called GALAD for the early detection of liver cancer. The TRACER study, a multi-center trial involving 15 U.S. sites, is assessing whether the GALAD model can improve screening accuracy in patients at high risk for hepatocellular carcinoma (HCC), the most common type of liver cancer.
The trial includes the use of two in vitro diagnostic tests developed by FUJIFILM Healthcare Americas Corporation — AFP-L3 and des-gamma-carboxyprothrombin (DCP) — which are part of the GALAD algorithm. The GALAD score incorporates gender, age, and three biomarkers (AFP, AFP-L3, and DCP) to evaluate a patient’s risk of developing liver cancer.
Traditional screening methods, such as liver ultrasounds and serum alpha-fetoprotein (AFP) tests, have limitations in detecting early-stage HCC, especially in patients with advanced liver disease or chronic hepatitis B. By comparison, the GALAD score has demonstrated greater diagnostic accuracy in recent studies, including the HCC Early Detection Strategy (HEDS) trial supported by the NCI’s Early Detection Research Network.
“TRACER aims to determine whether integrating blood-based biomarkers into liver cancer screening can shift detection to earlier, more treatable stages,” said Henry Izawa, president and CEO of Fujifilm Healthcare Americas. “With HCC cases continuing to rise, we hope this research reinforces the clinical value of our biomarker tests in routine surveillance.”
The TRACER study, which began enrolling patients in January 2024, will follow 5,500 individuals with cirrhosis or chronic hepatitis B over five and a half years. Participants will be randomly assigned to receive either standard screening (ultrasound with or without AFP) or surveillance using the GALAD model every six months. In addition to tracking cancer stage at diagnosis, researchers will also assess psychological and financial impacts of each screening approach.
The use of GALAD and its component biomarkers in this study remains for research purposes only. TRACER is supported through a grant under the NCI’s Early Detection Research Network, a key initiative within the National Institutes of Health aimed at advancing cancer screening technologies.
