Colo-rectal Cancer
Conditions
Keywords
colorectal cancer, colon cancer, early cancer detection
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.
Interventions
None listed
Sponsors
Natera, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes | 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. |
Countries
United States
Contacts
Primary ContactFIND-CRC Study team
Outcome results
None listed