| NCT ID | NCT07069556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Geneoscopy, Inc. |
| Condition | Colorectal Cancer (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,500 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,500 participants in total. It began in 2025-09-05 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07069556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069556 currently recruiting?
Yes, NCT07069556 is actively recruiting participants. Contact the research team at contact@geneoscopy.com for enrollment information.
Where is the NCT07069556 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07069556 clinical trial?
NCT07069556 is sponsored by Geneoscopy, Inc.. The trial plans to enroll 12,500 participants.
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