ColoSense Post-Approval Study

NCT07069556 | Recruiting FDA Device

• 1 other identifier: CT-PRT-0004
• Study Type: observational
• Target: 12,500
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (4)

• CRC Sensitivity

  ColoSense sensitivity for subjects with colorectal cancer (CRC), which is the percentage of individuals with a diagnosis of CRC that were detected as positive by the ColoSense test.

  Through study completion, an average of 5 years.

• AA Sensitivity

  ColoSense sensitivity for subjects with advanced adenomas (AA), which is the percentage of individuals with a diagnosis of AA that were detected as positive by the ColoSense test.

  Through study completion, an average of 5 years.

• SPL Sensitivity

  ColoSense sensitivity for subjects with serrated precancerous lesions (SPL), which is the percentage of individuals with a diagnosis of SPL that were detected as positive by the ColoSense test.

  Through study completion, an average of 5 years.

• NEG Specificity

  ColoSense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of negative findings that were detected as negative by the ColoSense test.

  Through study completion, an average of 5 years.

Interventions

ColoSense DEVICE

multi-target stool RNA test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 45 years or older, who are at typical average-risk of developing colorectal neoplasms and are considered enrolled after understanding and consenting to ICF. Additional subjects outside the intended us population can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geneoscopy, Inc.: lead

Study Sites (1)

Decentralized Study

St Louis, Missouri, 63146, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erica K Barnell, MD PhD

CONTACT

314-887-7777; contact@geneoscopy.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 16, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)