Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-84
SponsorUniversal Diagnostics

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

6,500 Participants
are grouped into 2 trial groups
Group A: Arm A
Group B: Arm B

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Through study completion to extend up to 24 months post LPI

Other outcomes

Sponsors and contacts

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