(CTN News) – For patients 45 years and older undergoing colorectal cancer screening, ColoSense, a novel multitarget stool RNA test (MT-sRNA), demonstrated strong performance in a phase 3 clinical trial published in JAMA.
The study was led by Dr. Erica K. Barnell, a professor at Washington University School of Medicine, in an attempt to evaluate the sensitivity and specificity of a test for mt-sRNA in comparison with the results of a colonoscopy.
A decentralized recruitment strategy, based on guidance from the US Food and Drug Administration, was used to enroll 45 and older individuals into the trial over the course of 12 months. There was a mean age of 55 years among the participants in this study.
A blinded, cross-sectional study was conducted in which all 8920 participants completed a mt-sRNA test as part of the study.
We used a commercially available fecal immunochemical test (FIT), a concentration of 8 RNA transcripts, and a self-reported smoking status to conduct the study.
A stool sample was collected from participants before they completed a colonoscopy at their local endoscopy center under the supervision of the researchers.
The results of the mt-sRNA test were compared with the index lesions found on colonoscopy as a result of the mt-sRNA test (positive or negative).
A total of 8920 patients were examined, of which 36 (0.4%) had colorectal cancer, while 606 (6.8%) had advanced adenomas.
As a result of the mt-sRNA test, the sensitivity for detecting colorectal cancer was 94% (95% confidence interval, 81%-99%), the sensitivity for detecting advanced adenomas was 46% (95% confidence interval, 42%-50%), and the specificity for detecting no lesions on colonoscopy was 88%.
The investigators reported that in terms of sensitivity, the mt-sRNA test detected lesions with the highest malignant transformation rates at a higher rate than those with lower malignant transformation rates (65.2% vs 42.9%, respectively; P .002).
Based on comparisons with FIT, the mt-sRNA test was found to have high sensitivity for detecting colorectal cancer (94% vs 78%, respectively; P=.01) and advanced adenomas (46% vs 29%, respectively; P=.001).
There was no significant difference between the type of test performed by the mt-sRNA in terms of specificity for no lesions on colonoscopy (95.7% vs 87.9%, respectively; P .001).
There were no serious adverse events observed by the researchers.
Based on the findings of the investigators, the mt-sRNA test may be a highly effective noninvasive diagnostic test for colorectal cancer and advanced adenomas.