NCT04739722

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

Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14,263 (actual)
• Sponsor: Geneoscopy, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer
• Advanced Adenocarcinoma
• Serrated Polyp

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ColoSense	ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Timeline

• Start date: 2021-04-12
• Primary completion: 2022-10-27
• Completion: 2024-01-31
• First posted: 2021-02-05
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study