Diagnostic Accuracy of Liquid Biopsy Compared to Traditional Biomarkers in Detecting HCC Recurrence: A Prospective Single-Center Study

Diagnostic Accuracy of Liquid Biopsy Compared to Traditional Biomarkers in Detecting HCC Recurrence: A Prospective Single-Center Study

Synopsis:

Background: Hepatocellular carcinoma (HCC) poses significant challenges in post-treatment surveillance due to the variable sensitivity and specificity of traditional biomarkers like Alpha-Fetoprotein (AFP) and Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA-II). The advent of cell-free DNA (cfDNA) offers a promising non-invasive alternative for the early detection of HCC recurrence, leveraging the genetic and epigenetic characteristics of tumors.

 Objectives: This study aims to assess the diagnostic accuracy of cfDNA in comparison to AFP and PIVKA-II for detecting HCC recurrence post-resection surgery or liver transplantation. It seeks to evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cfDNA, alongside its potential to enhance post-treatment surveillance and patient prognoses.

 Methods: In this prospective single-center study, we will consecutively enroll adult HCC patients who have undergone curative resection or liver transplantation. Blood samples will be collected at predetermined intervals for cfDNA, AFP, and PIVKA-II analysis, with regular imaging studies conducted to confirm recurrence. The study will employ droplet digital PCR (ddPCR) for cfDNA analysis, aiming to identify tumor-specific mutations and methylation patterns. Statistical analyses will compare the diagnostic performance of cfDNA against traditional biomarkers.

 Expected Outcomes: The study anticipates demonstrating superior sensitivity and specificity of cfDNA for early HCC recurrence detection compared to AFP and PIVKA-II. It also expects to highlight the cost-effectiveness and clinical utility of incorporating cfDNA into standard surveillance protocols, potentially leading to earlier therapeutic interventions and improved patient outcomes.

 Conclusion: By offering a detailed comparison between cfDNA and traditional biomarkers, this study aims to advance the understanding of cfDNA’s role in HCC surveillance. The findings could significantly impact clinical practices, fostering a shift towards more accurate, non-invasive monitoring methods for HCC recurrence, ultimately enhancing patient care and survival rates.