Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD

NCT07148297 | Recruiting

• 2 other identifiers: CRC-CPOCRENIS IS003779
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colo-rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of delta-HLD Technology for Colorectal Cancer

  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

Study Arms (2)

CRC Cases

Individuals with histologically confirmed colorectal adenocarcinoma

Controls

Individuals with negative colonoscopy results and no history of colorectal cancer

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Epiliquid Holding, Inc: lead

Study Sites (1)

Epiliquid

Mendoza, 5500, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma (cfDNA) samples collected from whole blood, tumor tissue samples (formalin-fixed or fresh-frozen) and normal colonic tissue collected from colorectal cancer patients at the time of diagnosis. Plasma samples will also be retained from colonoscopy-negative controls. All specimens will be used for biomarker analysis using delta-HLD technology.

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Dr. Victoria Bocanegra, MD, PhD.

CONTACT

+5492616603254; victoria.bocanegra@epiliquid.com

Dr. Emanuel Campoy, PhD.

CONTACT

+5492615997899; emanuel.campoy@epiliquid.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: June 30, 2021
• Primary Completion: August 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)