Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
ConditionColo-rectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorNatera, Inc.
About this trial
The FIND-CRC study is a prospective collection of samples and data from participants who are at average risk of developing colorectal cancer (CRC). Collected samples and data will be analyzed to evaluate the clinical performance of the Natera CRC Screening Test.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed informed consent.
40 years of age or older at the time of consent.
Planning or intending to undergo a standard of care colonoscopy.
Able to tolerate venipuncture for research draw(s).
Disqualifiers
Any prior history of any kind of malignancy (exception: participants who have undergone surgical removal of skin squamous cell or basal cell cancers may be enrolled, provided the procedure was completed at least 12 months prior to consent for the study).
Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
Undergoing diagnostic colonoscopy for the investigation of symptoms.
Up to date with colorectal cancer screening from any non-invasive test.
Trial population
Participants 40 years of age or older who are at average risk of colorectal cancer and scheduled for a screening colonoscopy as part of their standard of care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
25,000 Participants
are grouped into 1 trial groupGroup A: Participants at average risk for colorectal cancer
Trial outcomes
Primary outcomes
1
Primary Outcome
The primary outcomes of this study are sensitivity of the Natera CRC Screening Test for the detection of colorectal cancer (CRC) and specificity of the test for advanced neoplasia (AN), as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
Time frame
24 monthsSecondary outcomes
1
Secondary Outcomes
The secondary outcomes of this study are sensitivity and specificity of the Natera CRC Screening Test for the detection of Advanced Precancerous Lesions (APL) and specificity of the test for Negative findings, as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov