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

What this Trial Is About

Researchers are evaluating a new liquid biopsy technology called delta-HLD to detect hepatocellular carcinoma (HCC), a type of liver cancer. This proof-of-concept, observational case-control study aims to validate methylation-based biomarkers using a combination of enzymatic pre-treatment and multiplexed PCR detection. The study includes patients with confirmed HCC and those with liver cirrhosis but no cancer, to compare results and assess the diagnostic accuracy of this approach. The study collects blood plasma and liver tissue samples from both groups to analyze biomarkers and test how well the delta-HLD technology can detect tumor-specific methylation markers. The platform integrates a bioinformatic system that identifies and ranks these markers, allowing researchers to evaluate the sensitivity, specificity, and concordance between tissue and plasma tests. There are no interventions or treatments given, as this is an observational study focused on sample analysis. Participants will provide paired plasma and liver tissue samples, and researchers will perform molecular tests using PCR to measure biomarker signatures. The main outcome is to determine the sensitivity and specificity of the delta-HLD technology within three months. The study involves patients aged 18 to 75 with confirmed HCC or liver cirrhosis and monitors factors like cancer history and recent treatments. Participation involves providing samples and consent, with no active treatment involved.

Hepatocellular Carcinoma Identification Using Delta-HLD