Evaluation of the Natera Colorectal Cancer Screening Test in an Average Risk Population (FIND-CRC)

Natera

Status: Enrolling

Conditions: Colo-rectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07046585

25-080-ECP

Details and patient eligibility

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.

Full description

Participants who meet study inclusion criteria will be invited to enroll in the study and will provide written consent prior to study procedures. Participants will provide blood samples and will be required to have a colonoscopy performed within 120 days of their blood draw. No test results from the blood collection will be provided to participants or clinicians.

Enrollment: 25,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

25,000 participants in 1 patient group

Participants at average risk for colorectal cancer

Description:

Participants 40 years of age or older at time of consent, planning or intending to undergo asymptomatic screening colonoscopy.