Post-Approval Study of ColoSense Stool RNA Test for Colorectal Cancer Detection Evaluating Accuracy and Predictive Value in Adults 18 and Older

What this Trial Is About

Researchers are evaluating the ColoSense multi-target stool RNA test in a post-approval study to supplement existing data from a previous clinical trial. This observational study focuses on measuring clinical sensitivity, clinical specificity, positive predictive value, and negative predictive value of ColoSense in detecting colorectal cancer and related conditions. The study helps to better understand the accuracy of the test in a real-world setting. Participants will provide stool samples within 120 days before undergoing a colonoscopy. The study does not involve experimental treatments but observes the performance of ColoSense compared to colonoscopy findings over an average of 5 years. No investigational drugs or placebos are involved, as this is an observational device study. During the study, participants will undergo colonoscopy and provide stool samples as part of routine clinical care. Researchers will track outcomes such as colorectal cancer sensitivity, advanced adenoma sensitivity, serrated polyp sensitivity, and negative specificity over the study period. The study includes adults aged 18 and older, with follow-up continuing through study completion to monitor test accuracy and safety.

ColoSense Post-Approval Study