Hepatocellular Carcinoma Identification Using Delta-HLD (HIDE)

Epiliquid Holding, Inc

Status

Enrolling

Conditions

Hepato Cellular Carcinoma (HCC)

Study type

Observational

Funder types

Industry

Identifiers

NCT07148310

RENIS IS004112 (Other Identifier)

HCC-CPOC

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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