Hepatocellular Carcinoma Identification Using Delta-HLD
ConditionHepato Cellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorEpiliquid Holding, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other active cancers
Prior liver transplantation
Known hereditary cancer syndromes
Recent chemotherapy or antiviral treatment (<3 months)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: HCC-cases
Group B: Controls
Trial outcomes
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.
Time frame
Within 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov