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Clinical Trial
. 2023 Nov 14;330(18):1760-1768.
doi: 10.1001/jama.2023.22231.

Multitarget Stool RNA Test for Colorectal Cancer Screening

Erica K Barnell  1   2   3 , Elizabeth M Wurtzler  3 , Julie La Rocca  3 , Thomas Fitzgerald  3 , Jessica Petrone  4 , Yansheng Hao  5 , Yiming Kang  3 , Faith L Holmes  6 , David A Lieberman  7
Affiliations
Clinical Trial

Multitarget Stool RNA Test for Colorectal Cancer Screening

Erica K Barnell et al. JAMA. .

Erratum in

  • Error in Results.
    [No authors listed] [No authors listed] JAMA. 2024 Mar 12;331(10):888. doi: 10.1001/jama.2024.1637. JAMA. 2024. PMID: 38334985 Free PMC article. No abstract available.

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 nurse call center. All participants completed the mt-sRNA 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 mt-sRNA test results (positive or negative) were compared with index lesions observed on colonoscopy. Over the course of 12 months, individuals 45 years and older were enrolled in the clinical trial using the decentralized recruitment strategy. Participants were enrolled from 49 US states and obtained colonoscopies at more than 3800 different endoscopy centers.

Main outcomes and measures: The primary outcomes included the sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas and the specificity for no lesions on colonoscopy.

Results: The mean (range) age of participants was 55 (45-90) years, with 4% self-identified as Asian, 11% as Black, and 7% as Hispanic. Of the 8920 eligible participants, 36 (0.40%) had colorectal cancer and 606 (6.8%) had advanced adenomas. The mt-sRNA test sensitivity for detecting colorectal cancer was 94%, sensitivity for detecting advanced adenomas was 46%, and specificity for no lesions on colonoscopy was 88%. The mt-sRNA test showed significant improvement in sensitivity for colorectal cancer (94% vs 78%; McNemar P = .01) and advanced adenomas (46% vs 29%; McNemar P < .001) compared with results of the FIT.

Conclusions and relevance: In individuals 45 years and older, the mt-sRNA test showed high sensitivity for colorectal neoplasia (colorectal cancer and advanced adenoma) with significant improvement in sensitivity relative to the FIT. Specificity for no lesions on colonoscopy was comparable to existing molecular diagnostic tests.

Trial registration: ClinicalTrials.gov Identifier: NCT04739722.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Barnell reported receiving personal fees from Geneoscopy during the conduct of the study and having a patent for US 11479824B2 issued, a patent for US 11479820B2 issued, a patent for US 20230203591A1 pending, and a patent for US 20220177976A1 pending and being employed by and owning equity in Geneoscopy. Dr Wurtzler reported a patent for US 11479820 B2 issued and a patent for US 11479824 B2 issued. Dr La Rocca reported acting as CRO for Elligo during the conduct of the study and being employed by Geneoscopy. Dr Hao reported receiving personal fees from Elligo Health Research during the conduct of the study. Dr Kang reported receiving personal fees from Geneoscopy during the conduct of the study and having a patent for US 11,479,820 issued and a patent for US 11,479,824 issued. Dr Holmes reported receiving grants from Elligo Health Research and research fees from Geneoscopy during the conduct of the study. Dr Lieberman reported receiving personal fees from Geneoscopy during the conduct of the study and personal fees from ColoWrap and CapCheck outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participants Enrolled in the CRC-PREVENT Clinical Trial
Figure 2.
Figure 2.. Sensitivity and Specificity of the Multitarget Stool RNA (mt-sRNA) Test and the Fecal Immunochemical Test (FIT) for Index Lesions Observed on Colonoscopy
The mt-sRNA test receiver operating characteristic area under the curve (AUC) evaluated colorectal cancer (CRC) and advanced adenoma (AA) findings compared with all other findings (medium-risk adenomas, low-risk adenomas, and no findings).
See this image and copyright information in PMC

Comment in

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