Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD (CASCADE)

August 22, 2025 updated by: Epiliquid Holding, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 45 to 75 years from an average-risk population for colorectal cancer, undergoing colonoscopy or colorectal surgery at participating clinical sites in Argentina.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CRC Cases
Individuals with histologically confirmed colorectal adenocarcinoma
Controls
Individuals with negative colonoscopy results and no history of colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of delta-HLD Technology for Colorectal Cancer
Time Frame: 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.
Within 3 months after sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epiliquid Holding, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-CPOC
  • RENIS IS003779 (Other Identifier: Epiliquid Holding, Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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