Actively Recruiting
ColoSense Post-Approval Study
Led by Geneoscopy, Inc. · Updated on 2025-11-21
12500
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
CONDITIONS
Official Title
ColoSense Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is male or female, 45 years of age or older (subjects aged 18-45 can be enrolled but are not eligible for primary endpoint analysis)
- Subject can understand the study procedures and provides consent, including HIPAA medical release
- Subject is able and willing to provide stool samples within 120 days before a colonoscopy
- Subject is able and willing to undergo a colonoscopy after providing a stool sample
You will not qualify if you...
- Subject had any precancerous findings on most recent colonoscopy (excluding benign or hyperplastic polyps)
- Subject has a history or diagnosis of colorectal cancer
- Subject has a history of aerodigestive tract cancer
- Subject had a positive non-invasive screening test within recommended intervals: fecal occult blood or fecal immunochemical test within 12 months, or FIT-DNA test within 36 months
- Subject had a colonoscopy in the previous 9 years
- Subject had prior colorectal surgery except for sigmoid diverticular disease
- Colonoscopy was indicated due to overt rectal bleeding within the previous 30 days (blood on toilet paper after wiping does not count)
- Subject has or had high-risk conditions for colorectal cancer, including inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome, or other hereditary cancer syndromes such as Peutz-Jeghers Syndrome, MYH-Associated Polyposis, Gardner's Syndrome, Turcot's Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis, and Familial Hyperplastic Polyposis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Decentralized Study
St Louis, Missouri, United States, 63146
Actively Recruiting
Research Team
E
Erica K Barnell, MD PhD
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
0
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