Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorEpiliquid Holding, Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior history of colorectal cancer

Inflammatory bowel disease

Known hereditary cancer syndromes (e.g., Lynch, FAP)

Other active malignancies

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 2 trial groups
Group A: CRC Cases
Group B: Controls

Trial outcomes

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.

Time frame
Within 3 months after sample collection

Secondary outcomes

Other outcomes

Sponsors and contacts

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