ColoSense Post-Approval Study

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Geneoscopy, Inc.
Study ID
NCT07069556
Status
Recruiting
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Conditions

  • Colorectal Cancer (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ColoSense — DEVICE
    multi-target stool RNA test

Study Details

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.

Key Dates

Start date
Sep 5, 2025
Status verified
Nov 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
12,500 participants (estimated)

Primary Outcome Measure

CRC Sensitivity [ Time Frame: Through study completion, an average of 5 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Decentralized StudySt LouisMissouri63146
Erica K Barnell, MD PhD
[email protected]
314-887-7777

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