基于粪便的miR-92a对晚期结直肠肿瘤的诊断效能：一项前瞻性多中心筛查试验
Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial.
作者信息
Wang Jia-Chen, Zhao Li, Yu Xiang-Yang, Wu Ting-Ping, Xia Chang-Fa, Shi Ju-Fang, He Hui, Chen Zhi-Qi, Shi Dan, Xue Han, Ao Qi, Liao Shu-Ping, Zheng Zhang-Qiang, Huang Qiong-Fang, Li Lin, Lin Sui-Ling, Li Ying-Xue, Hu Wen-Long, Peng Ji, Lei Lin, Cao Mao-Mao, Yang Fan, Yan Xin-Xin, He Si-Yi, Cao Meng-Di, Zhang Shao-Li, Teng Yi, Li Qian-Ru, Tan Nuo-Pei, Yu Hao-Yang, Cheng Hong-Hui, Wang Xi-Mo, Wu Wei-Qing, Chen Wan-Qing
机构信息
Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
Department of Health Management, Shenzhen People's Hospital, the Second Clinical Medical College of Jinan University/the First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518053, Guangdong, China.
出版信息
Mil Med Res. 2025 Jun 13;12(1):30. doi: 10.1186/s40779-025-00613-3.
BACKGROUND
More efficacious, noninvasive screening methods are needed for advanced colorectal neoplasia. miR-92a is a reliable and reproducible biomarker for early colorectal cancer detection in stool samples. We compared the diagnostic efficacies of miR-92a, immunochemical fecal occult blood testing (FIT), and their combination (FIT + miR-92a) in a prospective multicenter screening trial.
METHODS
Overall, 16,240 participants aged 30-75 years were enrolled between April 1, 2021, and December 31, 2023. A total of 15,586 participants returned samples available for both FIT and miR-92a tests. All those with positive, and a random selection of those with negative screening tests were recommended to undergo colonoscopy. Follow-ups were performed until participants completed the colonoscopic examination. A total of 1401 screen-positive and 2079 randomly selected screen-negative individuals completed colonoscopies. Primary outcomes included sensitivity, number needed to screen (NNS), Youden index and receiver operating characteristic area under the curve (AUC) for advanced adenomas and colorectal cancer [advanced neoplasia (AN)] for each screening modality in the diagnostic performance analysis.
RESULTS
Colonoscopy was performed in 3480 individuals. The colonoscopy compliance rate was 47.8% for screen-positive individuals. The sensitivity of miR-92a versus FIT for AN was 70.9% versus 54.3% (P < 0.001), NNS was 24.7 versus 32.2 (P = 0.001), Youden index was 47.9% versus 35.0% (P < 0.001), AUC was 0.74 versus 0.67 (P = 0.010). FIT + miR-92a had a sensitivity of 85.4%, an NNS of 20.5, a Youden index of 47.9% and an AUC of 0.74 for AN.
CONCLUSIONS
For AN screening, miR-92a demonstrated better sensitivity, NNS, Youden index and AUC as compared with FIT. Compared with FIT, using miR-92a appears to be more efficient for population-based screening programs. Screening sensitivity for AN can be further enhanced if conditionally used in combination with FIT.
TRIAL REGISTRATION
Chinese Clinical Trial Registration Number: ChiCTR2200065415.
背景
对于晚期结直肠肿瘤，需要更有效的非侵入性筛查方法。miR-92a是粪便样本中早期结直肠癌检测的可靠且可重复的生物标志物。我们在一项前瞻性多中心筛查试验中比较了miR-92a、免疫化学粪便潜血试验（FIT）及其联合检测（FIT + miR-92a）的诊断效能。
方法
总体而言，2021年4月1日至2023年12月31日期间招募了16240名年龄在30 - 75岁的参与者。共有15586名参与者返回了可用于FIT和miR-92a检测的样本。所有筛查结果为阳性的参与者，以及随机选择的筛查结果为阴性的参与者均被建议接受结肠镜检查。随访持续进行，直至参与者完成结肠镜检查。共有1401名筛查阳性者和2079名随机选择的筛查阴性者完成了结肠镜检查。在诊断性能分析中，主要结局包括每种筛查方式对晚期腺瘤和结直肠癌[晚期肿瘤（AN）]的敏感性、筛查所需人数（NNS）、约登指数和受试者操作特征曲线下面积（AUC）。
结果
3480人接受了结肠镜检查。筛查阳性者的结肠镜检查依从率为47.8%。miR-92a对AN的敏感性为70.9%，而FIT为54.3%（P < 0.001），NNS分别为24.7和32.2（P = 0.001），约登指数分别为47.9%和35.0%（P < 0.001），AUC分别为0.74和0.67（P = 0.010）。FIT + miR-92a对AN的敏感性为85.4%，NNS为20.5，约登指数为47.9%，AUC为0.74。
结论
对于AN筛查，与FIT相比，miR-92a在敏感性、NNS、约登指数和AUC方面表现更好。与FIT相比，使用miR-92a似乎对基于人群的筛查项目更有效。如果有条件地与FIT联合使用，AN的筛查敏感性可进一步提高。
试验注册
中国临床试验注册号：ChiCTR2200065415。
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