Hepatocellular Carcinoma Identification Using Delta-HLD

NCT07148310 | Recruiting

• 2 other identifiers: HCC-CPOCRENIS IS004112
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepato Cellular Carcinoma (HCC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of delta-HLD Technology

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

  Within 3 months

Study Arms (2)

HCC-cases

Patients with histologically confirmed hepatocellular carcinoma

Controls

Patients with liver cirrhosis without evidence of HCC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Epiliquid Holding, Inc: lead

Study Sites (1)

Epiliquid

Mendoza, 5500, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma (cfDNA) samples from whole blood. Hepatocellular carcinoma and cirrhotic liver tissue samples (formalin-fixed and/or fresh-frozen). All samples used for biomarker analysis via delta-HLD

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Dr. Victoria Bocanegra, MD, PhD.

CONTACT

+5492616603254; victoria.bocanegra@epiliquid.com

Dr. Emanuel Campoy, PhD.

CONTACT

+5492615997899; emanuel.campoy@epiliquid.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: May 18, 2023
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

AR (1)