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期刊来源：JAMA

文献发表时间：2023-10-23

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2811133

关键点内容如下：

问题

新型多靶点粪便RNA（mt-sRNA）检测（ColoSense）在45岁及以上接受结直肠癌筛查的个体中的表现如何？、

调查结果

一项关键的前瞻性横断面临床试验包括8920名合格参与者，用于评估与结肠镜检查相比，MT-sRNA检测的敏感性和特异性。mt-sRNA检测检测结直肠癌的敏感性为94%，检测进展期腺瘤的敏感性为46%，结肠镜检查无病变的特异性为88%。

意义

MT-sRNA测试在所有年龄组中都表现出色，包括45岁及以上的人群。与其他分子诊断试验相比，MT-sRNA试验显示出检测结直肠肿瘤的高敏感性，并达到相似的特异性水平。

摘要内容如下：

重要性

结直肠癌筛查的非侵入性检查必须包括对结直肠癌和癌前病变的敏感检测。这些测试必须针对预期使用人群进行验证，包括45岁或以上的平均风险个体。评估非侵入性多靶点粪便RNA（mt-sRNA）检测（ColoSense）的敏感性和特异性，并与结肠镜检查结果进行比较。

研究设计和参与者

该3期临床试验（CRC-PREVENT）是一项盲法、前瞻性、横断面研究，旨在支持III类医疗器械的上市前批准申请。共有8920名参与者通过社交媒体平台在线确定，并于2021年6月至2022年6月通过分散的护士呼叫中心注册。所有参与者都完成了MT-sRNA测试，该测试结合了商业上可获得的粪便免疫化学测试（FIT）、8种RNA转录物的浓度和参与者报告的吸烟状态。参与者在当地内窥镜检查中心完成结肠镜检查之前收集粪便样本。将MT-sRNA检测结果（阳性或阴性）与结肠镜检查中观察到的指数病变进行比较。在为期12个月的过程中，使用分散招募策略招募45岁及以上的个体参加临床试验。参与者来自美国49个州，并在3800多个不同的内窥镜中心接受了结肠镜检查。

主要结局和措施

主要结果包括mt-sRNA检测检测结直肠癌和进展期腺瘤的敏感性以及结肠镜检查无病变的特异性。

结果

参与者的平均（范围）年龄为55（45-90）岁，4%的人自认为是亚洲人，11%的人自认为是黑人，7%的人自认为是西班牙裔。在8920名符合条件的参与者中，36人（0.40%）患有结直肠癌，606人（6.8%）患有晚期腺瘤。MT-sRNA检测检测结直肠癌的敏感性为94%，检测进展期腺瘤的敏感性为46%，结肠镜检查无病变的特异性为88%。MT-sRNA检测显示对结直肠癌的敏感性显著提高（94%比78%；McNemar P=.01）和进展期腺瘤（46%vs 29%；McNemar P<.001）与拟合结果进行比较。

结论和相关性

在45岁及以上的个体中，MT-sRNA检测显示出对结直肠肿瘤（结直肠癌和进展期腺瘤）的高敏感性，相对于FIT，其敏感性显著提高。结肠镜检查无病变的特异性与现有的分子诊断试验相当。

英文原文如下：

Key Points

Question  What is the performance of the novel multitarget stool RNA (mt-sRNA) test (ColoSense) for individuals 45 years and older undergoing colorectal cancer screening?

Findings  A pivotal prospective, cross-sectional clinical trial comprising 8920 eligible participants was used to evaluate the sensitivity and specificity of the mt-sRNA test compared with a colonoscopy. The sensitivity of the mt-sRNA test for detecting colorectal cancer was 94%, the sensitivity for detecting advanced adenomas was 46%, and the specificity for no lesions on colonoscopy was 88%.

Meaning  The mt-sRNA test exhibited strong performance across all age groups, including those aged 45 years and older. The mt-sRNA test demonstrated high sensitivity for detecting colorectal neoplasia and achieved a similar level of specificity compared with other molecular diagnostic tests.

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.

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