Jia-Chen Wang, Li Zhao, Xiang-Yang Yu, Ting-Ping Wu, Chang-Fa Xia, Ju-Fang Shi, Hui He, Zhi-Qi Chen, Dan Shi, Han Xue, Qi Ao, Shu-Ping Liao, Zhang-Qiang Zheng, Qiong-Fang Huang, Lin Li, Sui-Ling Lin, Ying-Xue Li, Wen-Long Hu, Ji Peng, Lin Lei, Mao-Mao Cao, Fan Yang, Xin-Xin Yan, Si-Yi He, Meng-Di Cao, Shao-Li Zhang, Yi Teng, Qian-Ru Li, Nuo-Pei Tan, Hao-Yang Yu, Hong-Hui Cheng, Xi-Mo Wang, Wei-Qing Wu, Wan-Qing Chen
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引用次数: 0
Abstract
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.
期刊介绍：
Military Medical Research is an open-access, peer-reviewed journal that aims to share the most up-to-date evidence and innovative discoveries in a wide range of fields, including basic and clinical sciences, translational research, precision medicine, emerging interdisciplinary subjects, and advanced technologies. Our primary focus is on modern military medicine; however, we also encourage submissions from other related areas. This includes, but is not limited to, basic medical research with the potential for translation into practice, as well as clinical research that could impact medical care both in times of warfare and during peacetime military operations.
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