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NCT Number: NCT07046585

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

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Natera, Inc

Austin, Texas, 78753, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

7a. Inflammatory bowel disease. 7b. Known hereditary condition that would increase risk of colorectal cancer (example Lynch Syndrome).

Treatment and study plan

Primary outcomes

  1. Primary Outcome

    Time frame: 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.

Secondary outcomes

  1. Secondary Outcomes

    Time frame: 24 months

    The secondary outcomes of this study are sensitivity and specificity of the Natera CRC Screening Test for the detection of Advanced Precancerous Lesions (APL) and specificity of the test for Negative findings, as assessed by agreement of the Natera CRC Screening test with colonoscopy findings.

Study contacts

Contact information is provided by the study sponsor or research team.

FIND-CRC Study team

CONTACT

[email protected]

650-489-9050

Sponsors and collaborators

Lead sponsor

Natera, Inc.

Industry

Registry information

Acronym: FIND-CRC

Important dates

Study start
2025
Primary completion
2027
Study completion
2033
First posted
Jul 1, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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