Actively Recruiting
Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection
Led by Natera, Inc. · Updated on 2025-01-29
5000
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test.
CONDITIONS
Official Title
Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years of age or older at time of consent.
- Planning or intending to undergo asymptomatic screening colonoscopy.
- Able to tolerate venipuncture for research draw(s).
- Able and willing to provide blood samples within the 120 days prior to a colonoscopy procedure.
- Willing and able to comply with the study visit schedule and study requirements.
- Signed informed consent(s) must be obtained prior to participation in the study
You will not qualify if you...
- Any prior history of any kind of malignancy (except skin squamous cell or basal cell cancer removed at least 12 months prior).
- Had a complete colonoscopy with adequate bowel preparation in the previous 9 years.
- Undergoing diagnostic colonoscopy for symptoms like unexplained long-lasting diarrhea or overt rectal bleeding within the previous 30 days.
- Undergone colorectal cancer screening within recommended intervals including FOBT/FIT within 12 months, FIT-DNA test within 36 months, blood-based CRC screening within 36 months, CT colonography within 5 years, or flexible sigmoidoscopy within 5 years.
- Precancerous findings on most recent colonoscopy, excluding benign or hyperplastic polyps.
- Had prior colorectal resection except for sigmoid diverticular disease.
- Diagnosis or history of high-risk conditions for colorectal cancer such as inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome, or other hereditary cancer syndromes including Peutz-Jeghers Syndrome, MYH-Associated Polyposis, Gardners Syndrome, Turcots Syndrome, Cowdens Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis, and Familial Hyperplastic Polyposis.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Natera
Austin, Texas, United States, 78753
Actively Recruiting
Research Team
N
Natera PROCEED-CRC Study team
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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