Recruiting

ColoSenseColoSense Post-Approval Study

Sponsor:

Geneoscopy, Inc.

Code:

NCT07069556

Conditions

Colorectal Cancer (Diagnosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ColoSense

Study Details

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.

Conditions

Colorectal Cancer (Diagnosis)

Study ID

NCT07069556

Start date

Sep 5, 2025

Status verified date

Nov, 2025

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

12500 participants

Anticipated

Interventions and Outcome Measures

Interventions

ColoSense

multi-target stool RNA test

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Erica K Barnell, MD PhD

314-887-7777 contact@geneoscopy.com

Locations

Decentralized Study

Recruiting

St Louis, Missouri, United States, 63146

Contacts

Erica K Barnell, MD PhD

314-887-7777 contact@geneoscopy.com

More Information

Sponsor

Geneoscopy, Inc.

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Geneoscopy, Inc. on 2025-11-21.