1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [ashwinrammohan@gmail.com].
   


6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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.