HIDE (Hepatocellular Carcinoma Identification via Delta-HLD) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, in detecting hepatocellular carcinoma (HCC). The study includes both plasma and tissue samples to assess biomarker concordance and evaluate diagnostic sensitivity and specificity using tumor-specific methylation markers detected by PCR.

This observational case-control study aims to validate a set of methylation-based biomarkers for HCC detection using delta-HLD technology, which combines enzymatic pre-treatment and multiplexed PCR detection. Epiliquid's proprietary platform also integrates a bioinformatic system that identifies and ranks tumor-specific methylation biomarkers. The study will enroll two groups: patients with histologically confirmed HCC (cases) and patients with liver cirrhosis without evidence of cancer (controls). Liver tissue and blood samples (cfDNA) will be analyzed to assess the sensitivity, specificity, and plasma-tissue concordance of the selected epigenetic signature.

Inclusion Criteria:

• Histologically confirmed HCC (cases) or clinically confirmed liver cirrhosis without HCC (controls)
• Willing and able to provide informed consent
• Available paired plasma and liver tissue sample

Exclusion Criteria:

• Other active cancers
• Prior liver transplantation
• Known hereditary cancer syndromes
• Recent chemotherapy or antiviral treatment (<3 months)

Eligible subjects will be men and women aged 18 years or older, representative of the at-risk population for hepatocellular carcinoma (HCC) in Argentina.