NCT07148310

Hepatocellular Carcinoma Identification Using Delta-HLD

Proof-of-Concept Case-Control Study for Hepatocellular Carcinoma Identification Using Delta-HLD Technology (HIDE)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Epiliquid Holding, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepato Cellular Carcinoma (HCC)

Timeline

• Start date: 2023-05-18
• Primary completion: 2026-08-12
• Completion: 2026-12-01
• First posted: 2025-08-29
• Last updated: 2025-09-09

Locations

1 site across 1 country: Argentina