Detecting hepatocellular carcinoma with the Delta-HLD blood test
Proof-of-Concept Case-Control Study for Hepatocellular Carcinoma Identification Using Delta-HLD Technology (HIDE)
This project will test whether the Delta-HLD liquid biopsy can detect hepatocellular carcinoma (HCC) using blood and matched liver tissue from people with HCC and from people with cirrhosis without cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Epiliquid Holding, Inc Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mendoza) |
| Trial ID | NCT07148310 on ClinicalTrials.gov |
What this trial studies
HIDE is a proof-of-concept case-control observational study that tests a set of tumor-specific DNA methylation markers using Epiliquid's Delta-HLD platform. The platform combines enzymatic pre-treatment and multiplexed PCR with a bioinformatics pipeline to identify and rank methylation biomarkers in cfDNA. The study will enroll patients with histologically confirmed HCC (cases) and patients with liver cirrhosis but no evidence of cancer (controls) and will analyze paired plasma and liver tissue samples. Outcomes include diagnostic sensitivity, specificity, and concordance between plasma and tissue methylation signals.
Who should consider this trial
Good fit: Ideal participants are adults with histologically confirmed HCC or adults with clinically confirmed liver cirrhosis without HCC who can provide informed consent and paired plasma and liver tissue samples.
Not a fit: Patients with other active cancers, prior liver transplantation, known hereditary cancer syndromes, or recent chemotherapy or antiviral treatment (within three months) are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive blood-based test to help detect HCC earlier and more accurately than current methods.
How similar studies have performed: Other research using cfDNA methylation markers for HCC detection has shown promising preliminary results but remains largely investigational and not yet standard of care.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Mendoza
- Epiliquid — Mendoza, Argentina (Recruiting)
Study contacts
- Study coordinator: Dr. Victoria Bocanegra, MD, PhD.
- Email: victoria.bocanegra@epiliquid.com
- Phone: +5492616603254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.