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NCT Number: NCT07148310

Hepatocellular Carcinoma Identification Using Delta-HLD

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.

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Key information

Conditions

Hepato Cellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Sensitivity and Specificity of delta-HLD Technology

    Time frame: Within 3 months

    Diagnostic performance of delta-HLD-detected methylation biomarkers in plasma and tissue, using clinical diagnosis of HCC (confirmed by histopathology) as the reference standard.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Emanuel Campoy, PhD.

CONTACT

[email protected]

+5492615997899

Dr. Victoria Bocanegra, MD, PhD.

CONTACT

[email protected]

+5492616603254

Sponsors and collaborators

Lead sponsor

Epiliquid Holding, Inc

Industry

Registry information

Official study title

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

Acronym: HIDE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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