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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07148297

Acronym

CASCADE

Enrollment

600

Registered

2025-08-29

Start date

2021-06-30

Completion date

2026-12-31

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer

Keywords

Colorectal cancer, Epigenetics, Liquid Biopsy, cfDNA, Biomarker, Methylation, PCR

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Candidate for colonoscopy or colorectal surgery * Willing and able to provide informed consent * Able to provide blood and/or tissue sample before treatment or resection

Exclusion criteria

* Prior history of colorectal cancer * Inflammatory bowel disease * Known hereditary cancer syndromes (e.g., Lynch, FAP) * Other active malignancies * Recent chemotherapy or immunosuppressive treatment

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity of delta-HLD Technology for Colorectal Cancer	Within 3 months after sample collection	Diagnostic performance of methylation biomarkers detected using delta-HLD technology in plasma and tissue samples, using colonoscopy and histopathology as the clinical reference standard.

Countries

Argentina

Contacts

Primary ContactDr. Victoria Bocanegra, MD, PhD.

victoria.bocanegra@epiliquid.com+5492616603254

Backup ContactDr. Emanuel Campoy, PhD.

emanuel.campoy@epiliquid.com+5492615997899

Outcome results