RecruitingNCT07069556

ColoSense Post-Approval Study

ColoSense Post Approval Study


Sponsor

Geneoscopy, Inc.

Enrollment

12,500 participants

Start Date

Sep 5, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on how well the ColoSense stool DNA test (a non-invasive at-home colorectal cancer screening test) performs in a broad population — comparing results to colonoscopy findings to confirm the test's accuracy after its approval. **You may be eligible if...** - You are 45 or older (those 18–44 may enroll but are not part of the primary analysis) - You are willing and able to provide a stool sample and then undergo a colonoscopy afterward **You may NOT be eligible if...** - You have a history of colorectal cancer or precancerous polyps - You have had a colonoscopy in the past 9 years - You have inflammatory bowel disease (IBD), Lynch syndrome, or familial adenomatous polyposis (FAP) - You have recently had a positive non-invasive cancer screening test - You have had active rectal bleeding in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEColoSense

multi-target stool RNA test


Locations(1)

Decentralized Study

St Louis, Missouri, United States

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NCT07069556


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