The Fatty Liver, Cirrhosis, and Liver Cancer Study (TENDENCY): Protocol for a Multicenter Case-Control Study

Area of Science:

• Hepatology and Oncology
• Biomarker Discovery
• Diagnostic Research

Background:

• Hepatocellular cancer (HCC) presents high mortality rates, necessitating improved early detection methods.
• Current screening tools for HCC, including alpha fetoprotein and ultrasound, exhibit limited sensitivity.
• Patients with cirrhosis, particularly from nonalcoholic fatty liver disease and viral hepatitis, are at elevated risk for HCC development.

Purpose of the Study:

• To validate novel noninvasive screening markers for hepatocellular cancer (HCC) diagnosis.
• To assess methylated septin 9, urinary volatile organic compounds, and urinary peptides as potential HCC biomarkers.
• To investigate these biomarkers within the context of liver disease management.

Main Methods:

• A multicenter, nested case-control study design was employed.
• Plasma methylated septin 9 levels were compared between HCC cases and cirrhosis controls.
• Urine samples were analyzed for HCC-specific volatile organic compounds and peptides using advanced spectrometry techniques.

Main Results:

• Participant recruitment for the TENDENCY study concluded in March 2023.
• The study is currently undergoing data analysis, with completion anticipated by November 2023.

Conclusions:

• Effective screening tests for hepatocellular cancer remain a critical unmet need.
• The integration of sensitive plasma and urinary biomarkers could enhance early HCC detection.
• Improved early detection through novel biomarkers holds the potential to significantly improve patient outcomes in HCC.