Hepatocellular Carcinoma Identification Using Delta-HLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepato Cellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Proof-of-Concept Case-Control Study for Hepatocellular Carcinoma Identification Using Delta-HLD Technology (HIDE)
Overview
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.
Primary outcome measures
- Sensitivity and Specificity of delta-HLD Technology [Time frame: Within 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Argentina · 1 center
- Epiliquid — Mendoza
Identifiers
NCT: NCT07148310 · HCC-CPOC · RENIS IS004112