Natera blood-based colorectal cancer screening for average-risk adults

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

This will test whether Natera's blood-based colorectal cancer screening can find cancer in average-risk adults who are planning a colonoscopy.

Quick facts

• Study type: Observational
• Enrollment: 25000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Natera, Inc. (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT07046585 on ClinicalTrials.gov

What this trial studies

FIND-CRC is a prospective observational collection of blood samples and clinical data from average-risk adults who plan to undergo a standard-of-care colonoscopy. Participants provide a research blood draw within 120 days before their colonoscopy, and samples will be analyzed to determine how the Natera CRC Screening Test performs compared with colonoscopy findings. No blood test results are returned to participants or their clinicians, and enrollment excludes people with prior malignancies or recent/up-to-date CRC screening. The study is conducted by the sponsor at a single site in Austin, Texas.

Who should consider this trial

Good fit: Adults aged 40 or older at average risk for colorectal cancer who are planning a standard-of-care colonoscopy and can provide a blood sample within 120 days of the procedure.

Not a fit: People under 40, those with a prior history of cancer, those having a diagnostic colonoscopy for symptoms, or those already up-to-date with non-invasive CRC screening are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the blood test could offer a less invasive screening option that detects colorectal cancer earlier and may increase screening participation.

How similar studies have performed: Other blood-based and methylation-based CRC screening tests have shown some ability to detect colorectal cancer, but results vary and further validation in average-risk populations is still needed.

Eligibility criteria

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).

Where this trial is running

Austin, Texas

• Natera, Inc — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: FIND-CRC Study team

Conditions Colo-rectal Cancer; colorectal cancer; colon cancer; early cancer detection