Actively Recruiting
ColoSense Post Approval Study for Colorectal Cancer Detection
Led by Geneoscopy, Inc. · Updated on 2025-11-21
12500
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ColoSense multi-target stool RNA test in a post-approval study to supplement existing data from a previous clinical trial. This observational study focuses on measuring clinical sensitivity, clinical specificity, positive predictive value, and negative predictive value of ColoSense in detecting colorectal cancer and related conditions. The study helps to better understand the accuracy of the test in a real-world setting. Participants will provide stool samples within 120 days before undergoing a colonoscopy. The study does not involve experimental treatments but observes the performance of ColoSense compared to colonoscopy findings over an average of 5 years. No investigational drugs or placebos are involved, as this is an observational device study. During the study, participants will undergo colonoscopy and provide stool samples as part of routine clinical care. Researchers will track outcomes such as colorectal cancer sensitivity, advanced adenoma sensitivity, serrated polyp sensitivity, and negative specificity over the study period. The study includes adults aged 18 and older, with follow-up continuing through study completion to monitor test accuracy and safety.
CONDITIONS
Brief 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 is able to understand study procedures and provide consent
- Subject authorizes release of relevant protected health information
- Subject is able and willing to provide stool samples within 120 days prior to colonoscopy
- Subject is able and willing to undergo colonoscopy after providing stool sample
You will not qualify if you...
- Subject had any precancerous findings on most recent colonoscopy excluding benign or hyperplastic polyps
- Subject has history or diagnosis of colorectal cancer
- Subject has history of aerodigestive tract cancer
- Subject had positive non-invasive screening test within recommended intervals (fecal occult blood or immunochemical test within 12 months, FIT-DNA test within 36 months)
- Subject had colonoscopy within previous 9 years
- Subject had prior colorectal resection except for sigmoid diverticular disease
- Indication for colonoscopy was overt rectal bleeding within previous 30 days (blood on toilet paper does not count)
- Subject has diagnosis or history of high-risk colorectal cancer conditions including inflammatory bowel disease, familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome, or other hereditary cancer syndromes listed in criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 days before colonoscopy
Participants provide stool samples for the ColoSense multi-target stool RNA test prior to undergoing colonoscopy.
1 visit for stool sample collection
Duration - 1 day
Participants undergo colonoscopy to evaluate colorectal health following stool sample collection.
1 visit (in-person)
Duration - Approximately 5 years
Participants are monitored for colorectal cancer detection outcomes over an average of 5 years through study completion.
Periodic assessments as per routine care
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
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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