ColoSense for colorectal cancer screening
ColoSense Post Approval Study
This post-approval study will test how well the ColoSense stool test detects colorectal cancer in adults (primary analysis for ages 45 and older) who provide a stool sample before a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geneoscopy, Inc. Industry-sponsored |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07069556 on ClinicalTrials.gov |
What this trial studies
This is an observational post-approval study supplementing data from the CRC-PREVENT trial to measure real-world performance of the ColoSense test. Participants provide a stool sample within 120 days before undergoing a colonoscopy, and ColoSense results are compared to colonoscopy findings to calculate clinical sensitivity, specificity, positive predictive value, and negative predictive value. Adults 45 and older are the primary population for endpoint analysis, while younger enrollees may be included but not counted in primary endpoints. Individuals with prior colorectal cancer, aerodigestive tract cancer, or recent precancerous findings are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults planning a colonoscopy who are willing to provide a stool sample within 120 days beforehand, are at least 45 years old for the primary analysis, and do not have a history of colorectal or aerodigestive tract cancer.
Not a fit: People with a history of colorectal cancer, recent precancerous findings, or those under 45 (for primary endpoints) are unlikely to benefit from this study's primary outcomes.
Why it matters
Potential benefit: If successful, this study could give clearer real-world data on ColoSense accuracy and help clinicians and patients make better screening decisions.
How similar studies have performed: This PAS builds on data from the CRC-PREVENT clinical trial and follows the broader body of research showing that stool-based colorectal cancer tests can achieve clinically useful sensitivity and specificity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis)
* Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
* Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
* Subject is able and willing to undergo a colonoscopy after providing a stool sample
Exclusion Criteria:
* Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
* Subject has a history or diagnosis of colorectal cancer
* Subject has a history of aerodigestive tract cancer
* Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals:
* Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
* FIT-DNA test within the previous 36 months
* Subject has had a colonoscopy in the previous nine (9) years.
* Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
* Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
* Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
* Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
* Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
* Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
* Other hereditary cancer syndromes including but are not limited to:
* Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome
* Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis
* Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
Where this trial is running
St Louis, Missouri
- Decentralized Study — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Erica K Barnell, MD PhD
- Email: contact@geneoscopy.com
- Phone: 314-887-7777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.