Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)
Recruiting · NCT07046585 · Observational (researchers observe without assigning treatment) · Lead sponsor: Natera, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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).
- Able and willing to provide blood samples within the 120 days prior to a standard-of-care pre-bowel preparation procedure and colonoscopy procedure.
- Willing and able to comply with the study visit schedule and study requirements.
Exclusion criteria
- 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.
- Precancerous findings on most recent colonoscopy.
- Had a prior colorectal resection for any reason other than sigmoid diverticular disease.
- Known personal history of any of the following high-risk conditions:
- a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).
Where it is running
1 location listed across 1 US state.
- Natera, Inc - Austin, Texas, United States