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

NCT07046585 | Recruiting

• 1 other identifier: 25-080-ECP
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

colorectal cancer; colon cancer; early cancer detection

Outcome Measures

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.

  24 months

Secondary Outcomes (1)

• Secondary Outcomes

  24 months

Study Arms (1)

Participants at average risk for colorectal cancer

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Signed informed consent.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (1)

Natera, Inc

Austin, Texas, 78753, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

FIND-CRC Study team

CONTACT

650-489-9050; findcrc_ctgov@natera.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 1, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): September 30, 2033
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)