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Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening

NCT04739722•Geneoscopy, Inc.

Summary

This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.

Detailed Description

This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. Subjects were recruited onto the clinical trial if they were average-risk subjects, or had a self-reported family history of CRC, aged 45 and older. All participants completed the ColoSense test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The ColoSense test result (positive or negative) was compared with index lesions observed on colonoscopy. The primary outcomes included ColoSense sensitivity for detecting colorectal cancer, advanced adenomas, or serrated precancerous lesions, and ColoSense specificity for all other findings.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is male or female, ≥45 years of age
•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 finding on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size (Note: Tissue biopsies that result in no histopathology findings are acceptable)
•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:
+4 more criteria

Locations (2)

Geneoscopy, Inc.

St Louis, Missouri, United States

Elligo Health Research

Austin, Texas, United States

Key Dates

Start Date

April 12, 2021

Primary Completion Date

October 27, 2022

Completion Date

January 31, 2024

Last Updated

October 1, 2024

Enrollment

14,263

ACTUAL participants

Conditions

Colorectal CancerAdvanced AdenocarcinomaSerrated Polyp

Interventions

ColoSense

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study

Inclusion Criteria

Exclusion Criteria

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