About this trial
This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Arm A: Diagnosed with CRC
Arm B: Undergoing screening with colonoscopy for CRC
Disqualifiers
Arm A: Undergoing treatment for CRC,
Arm B: Past history of CRC
Trial population
Prevalent colorectal cancer and people undergoing screening for colorectal cancer
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Development of assay
The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.
Secondary outcomes
ML Training
A portion of the samples will be used to train the ML algorithms and for assay development activities. Another purpose of the study is to collect samples to be used in Analytical Validation (Assay Verification) and system validation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.