National Liver Cancer Screening Trial (TRACER) Study Overview
Background
HCC Screening Recommendations: Guidelines suggest screening for liver cancer (HCC) in high-risk patients using ultrasound every six months, sometimes combined with a blood test for alpha-fetoprotein (AFP). However, this method often lacks effectiveness due to low patient adherence and sensitivity.
Potential Solution: Blood-based biomarker panels, like GALAD—which includes sex, age, and three specific blood markers (AFP, AFP-L3, and des-carboxy prothrombin)—may improve screening effectiveness. Previous studies have shown that GALAD has a high rate of accuracy, but it needs further testing in a large trial.
Methods
Trial Design: The TRACER study is a practical phase IV trial that started enrolling patients in January 2024. It compares ultrasound-based screening with GALAD biomarker-based screening in 5,500 patients suffering from chronic hepatitis B or cirrhosis.
Randomization: Patients are randomly assigned to one of two groups:
- Arm A: Ultrasound screening with or without AFP
- Arm B: GALAD biomarker screening
Recruitment: Participants are being recruited from 15 different healthcare sites over three years, with the main goal of reducing late-stage HCC assessed after 5.5 years.
Discussion
Expected Outcomes: The results will guide the best methods for screening and early detection of liver cancer in patients with chronic liver diseases. If GALAD proves to be more effective, it could shift the standard screening practice from ultrasound to the biomarker panel.
Trial Registration
NCT06084234
Trial Status
The TRACER Study is currently enrolling patients.
Clinical Trials and Their Importance
Advancing Treatments: Clinical trials are essential for developing safe and effective medical treatments. It’s crucial to integrate these findings into everyday healthcare practices.
DocSym Platform: Our AI-driven platform, DocSym, streamlines access to clinical protocols and research, making it easier for healthcare providers to stay informed.
Enhancing Patient Care: With our mobile apps, healthcare teams can manage scheduling, treatment monitoring, and telemedicine efficiently, improving patient care and expanding services.
AI Benefits: Utilizing AI can optimize clinic workflows, enhance patient outcomes, and reduce paperwork. Discover more at aidevmd.com.
