Blood-based delta-HLD methylation test for detecting colorectal cancer
Proof-of-concept Case-control Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CASCADE)
This will try a blood-based delta-HLD methylation test to see if it can detect colorectal cancer in people scheduled for colonoscopy or colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Epiliquid Holding, Inc Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mendoza) |
| Trial ID | NCT07148297 on ClinicalTrials.gov |
What this trial studies
CASCADE is a proof-of-concept case-control study comparing blood (plasma cfDNA) and tumor tissue from individuals with histologically confirmed colorectal cancer to controls with negative colonoscopy. Epiliquid's bioinformatic pipeline identifies and ranks colorectal-specific methylation biomarkers, which are detected using delta-HLD, a sequential enzymatic pre-treatment combined with PCR that enables sensitive, multiplexed detection. The study will measure diagnostic performance metrics including sensitivity, specificity, and concordance between blood and tissue in an average-risk population. Results will support validation of the integrated platform as a minimally invasive diagnostic approach for colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults at average colorectal cancer risk who are scheduled for colonoscopy or colorectal surgery and can provide blood and/or tissue samples before treatment.
Not a fit: Patients with prior colorectal cancer, inflammatory bowel disease, known hereditary cancer syndromes, other active malignancies, or recent chemotherapy or immunosuppression may not receive benefit from this test.
Why it matters
Potential benefit: If successful, this could provide a minimally invasive, blood-based way to detect colorectal cancer earlier and make screening more accessible.
How similar studies have performed: Other methylation-based liquid biopsies for colorectal cancer and multi-cancer detection have shown promise, but delta-HLD is a novel proprietary method that has not yet been tested in large clinical cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mendoza
- Epiliquid — Mendoza, Argentina (Recruiting)
Study contacts
- Study coordinator: Dr. Victoria Bocanegra, MD, PhD.
- Email: victoria.bocanegra@epiliquid.com
- Phone: +5492616603254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.