NCT07148297

Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD

Proof-of-concept Case-control Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CASCADE)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Epiliquid Holding, Inc · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CASCADE (Colorectal Analysis for Signature Cancer Assessment Using delta-HLD Technology) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, for the detection of colorectal cancer. Epiliquid also integrates a proprietary bioinformatic system capable of identifying, ranking, and selecting tumor-specific methylation biomarkers for different cancer types. In this study, colorectal cancer-specific biomarkers will be evaluated in blood and tissue samples using delta-HLD technology, which enables sensitive and multiplexed detection through PCR. Study results will support the validation of Epiliquid's integrated platform as a minimally invasive and accessible diagnostic solution for colorectal cancer.

Detailed description

This observational case-control study aims to evaluate the performance of delta-HLD technology in an average-risk colorectal cancer population. The CASCADE study seeks to validate the technical and diagnostic performance of Epiliquid's platform, which integrates a proprietary bioinformatic system designed to identify, rank, and select methylation-based biomarkers specific to each cancer type. For colorectal cancer, these biomarkers are selected and detected using delta-HLD technology, a proprietary method that combines sequential enzymatic pre-treatment with PCR-based amplification to enable sensitive, multiplexed detection. Blood (plasma cfDNA) and tumor tissue samples will be collected from two groups: individuals with histologically confirmed colorectal cancer (cases) and individuals with negative colonoscopy findings (controls). This proof-of-concept study will assess biomarker performance, including sensitivity, specificity, and concordance between blood and tissue samples.

Conditions

• Colo-rectal Cancer

Timeline

• Start date: 2021-06-30
• Primary completion: 2025-08-01
• Completion: 2026-12-01
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: Argentina