RecruitingNCT07168876

Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)

Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)


Sponsor

Epiliquid Holding, Inc

Enrollment

3,200 participants

Start Date

Apr 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC) detection. The study will evaluate the test performance in an average-risk population for CRC undergoing screening colonoscopy, which will serve as the gold standard reference.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Inclusion Criteria2

  • Men and women aged 45-75 years
  • Indication of colorectal cancer screening colonoscopy by treating physician

Exclusion Criteria6

  • First-degree family history of CRC
  • Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
  • Other malignancies within 5 years
  • Known hereditary CRC syndromes (Lynch, FAP)
  • Major trauma, surgery, transfusion in past 30 days
  • Current participation in an interventional clinical trial

Locations(1)

Epiliquid

Mendoza, Mendoza Province, Argentina

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NCT07168876


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