Actively Recruiting
Proof-of-concept Case-control Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CASCADE)
Led by Epiliquid Holding, Inc · Updated on 2025-08-29
600
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying colorectal cancer detection using Epiliquid's delta-HLD technology, a new liquid biopsy method that identifies tumor-specific methylation biomarkers. This proof-of-concept observational case-control study includes participants with confirmed colorectal adenocarcinoma and those with negative colonoscopy results. The study aims to assess the sensitivity, specificity, and agreement of delta-HLD biomarker detection in blood and tissue samples, validating its potential as a minimally invasive diagnostic tool. The study collects blood plasma and tumor tissue samples from two groups: individuals diagnosed with colorectal cancer and individuals showing no cancer signs through colonoscopy. Delta-HLD technology uses sequential enzymatic pre-treatment combined with PCR to sensitively and multiplexedly detect colorectal cancer biomarkers. Participants are grouped as cases or controls based on their diagnosis. No treatments are administered as this is an observational study. Participants will provide blood and/or tissue samples prior to any treatment or surgery. Researchers will analyze these samples to measure how accurately delta-HLD detects colorectal cancer biomarkers. The primary outcome is the sensitivity and specificity of delta-HLD within three months after sample collection. The study runs until December 2026 and involves adults aged 45 to 75 years. No interventions or therapies are applied during the study.
CONDITIONS
Brief Title
Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age between 45 and 75 years
You will not qualify if you...
- Prior history of colorectal cancer
- Inflammatory bowel disease
- Known hereditary cancer syndromes (e.g., Lynch, FAP)
- Other active malignancies
- Recent chemotherapy or immunosuppressive treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 3 months after sample collection
Participants undergo blood and tumor tissue sample collection to assess colorectal cancer biomarkers using delta-HLD technology.
1 to 2 visits depending on sample type
Duration - Up to 3 months after sample collection
Participants are observed to evaluate biomarker performance including sensitivity, specificity, and concordance between blood and tissue samples.
Follow-up assessments may occur depending on participant group
Trial Site Locations
Total: 1 location
1
Epiliquid
Mendoza, Argentina, 5500
Actively Recruiting
Research Team
D
Dr. Victoria Bocanegra, MD, PhD.
D
Dr. Emanuel Campoy, PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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