Evaluation of the Natera Colorectal Cancer Screening Test... | NCT07046585

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

NCT07046585

Sponsor

Natera, Inc.

Status

Recruiting

Last Update Posted

Dec 12, 2025Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Colo-rectal Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2025Actual

Primary Completion Date

Jul 10, 2027Estimated

Completion Date

Sep 30, 2033Estimated

First Submitted Date

Jun 13, 2025

First Submission Date that Met QC Criteria

Jun 27, 2025

First Posted Date

Jul 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25,000Estimated

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Secondary Outcomes	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.	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D003110	Colonic Neoplasms
D015179	Colorectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site