Multitarget Stool RNA Test for Colorectal Cancer Screening.

ABSTRACT:

Importance

Noninvasive tests for colorectal cancer screening must include sensitive detection of colorectal cancer and precancerous lesions. These tests must be validated for the intended-use population, which includes average-risk individuals 45 years or older.

Objective

To evaluate the sensitivity and specificity of a noninvasive, multitarget stool RNA (mt-sRNA) test (ColoSense) test compared with results from a colonoscopy.

Design, setting, and participants

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. A total of 8920 participants were identified online using social media platforms and enrolled from June 2021 to June 2022 using a decentralized n

SUBMITTER: Barnell EK 

PROVIDER: S-EPMC10594178 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature