Hepatocellular Carcinoma Identification Using Delta-HLD

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07148310

Acronym

HIDE

Enrollment

200

Registered

2025-08-29

Start date

2023-05-18

Completion date

2026-12-31

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

Hepatocellular carcinoma, Epigenetics, Liquid Biopsy, cfDNA, Biomarker, Methylation, PCR

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity of delta-HLD Technology	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.

Countries

Argentina

Contacts

Primary ContactDr. Victoria Bocanegra, MD, PhD.

victoria.bocanegra@epiliquid.com+5492616603254

Backup ContactDr. Emanuel Campoy, PhD.

emanuel.campoy@epiliquid.com+5492615997899

Outcome results