ColoSense Post-Approval Study

ColoSense Post Approval Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer (Diagnosis)
• Intervention / Treatment: Device: ColoSense

• Study Type: Observational
• Enrollment (Estimated): 12500

Contacts and Locations

• Study Contact: Name: Erica K Barnell, MD PhD; Phone Number: 314-887-7777; Email: contact@geneoscopy.com

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63146
      • Recruiting
      • Decentralized Study
      • Contact: Erica K Barnell, MD PhD; Phone Number: 314-887-7777; Email: contact@geneoscopy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Geneoscopy, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: June 27, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Disease
• Other Study ID Numbers: CT-PRT-0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No