NCT07069556Recruiting
ColoSense Post-Approval Study
ColoSense Post Approval Study
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 12500 (estimated)
- First submitted
- 27 Jun 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Geneoscopy, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07069556
What you commit to
- Study type: Observational
- Planned participants: 12500
- From Sept 2025 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Subject has a history or diagnosis of colorectal cancer
- Subject has a history of aerodigestive tract cancer
- 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
Other
- Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Decentralized Study Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.