Clinical Trials in the USA / NCT07046585
Recruiting
Observational
Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
NCT07046585 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Colo-rectal Cancer
Study summary
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
Inclusion Criteria:
1. Signed informed consent.
2. 40 years of age or older at the time of consent.
3. Planning or intending to undergo a standard of care colonoscopy.
4. Able to tolerate venipuncture for research draw(s).
5. Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.
6. Willing and able to comply with the study visit schedule and study requirements.
Exclusion Criteria:
1. 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).
2. Had a complete colonoscopy with adequate bowel preparation in the previous nine (9) years.
3. Undergoing diagnostic colonoscopy for the investigation of symptoms.
4. Up to date with colorectal cancer screening from any non-invasive test.
5. Precancerous findings on most recent colonoscopy.
6. Had a prior colorectal resection for any reason other than sigmoid diverticular disease.
7. Known personal history of any of the following high-risk conditions:
7a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).
Primary outcome measure(s)
- Primary Outcome — 24 months
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Natera, Inc | Austin | Texas | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07046585 on ClinicalTrials.gov ↗ ← All trials in the USA