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Observational Study
. 2025 Jun 13;12(1):30.
doi: 10.1186/s40779-025-00613-3.

Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial

Jia-Chen Wang #  1 , Li Zhao #  2 , Xiang-Yang Yu #  3 , Ting-Ping Wu #  4 , Chang-Fa Xia #  1 , Ju-Fang Shi #  1 , Hui He  2 , Zhi-Qi Chen  5 , Dan Shi  3 , Han Xue  2 , Qi Ao  3 , Shu-Ping Liao  2 , Zhang-Qiang Zheng  3 , Qiong-Fang Huang  2 , Lin Li  3 , Sui-Ling Lin  4 , Ying-Xue Li  6 , Wen-Long Hu  7 , Ji Peng  8 , Lin Lei  8 , Mao-Mao Cao  1 , Fan Yang  1 , Xin-Xin Yan  1 , Si-Yi He  1 , Meng-Di Cao  1 , Shao-Li Zhang  1 , Yi Teng  1 , Qian-Ru Li  1 , Nuo-Pei Tan  1 , Hao-Yang Yu  9 , Hong-Hui Cheng  10 , Xi-Mo Wang  11   12   13 , Wei-Qing Wu  14 , Wan-Qing Chen  15
Affiliations
Observational Study

Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial

Jia-Chen Wang et al. Mil Med Res. .

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.

Keywords: Advanced neoplasia; Colorectal cancer; Immunochemical fecal occult blood testing; MiR-92a; Screening.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethical reviews were conducted separately by the ethics committees of each clinical center [Ethics review committee of Shenzhen People’s Hospital (SYL-202123-03); Ethics review committee of Shenzhen Bao’an District Hospital of Traditional Chinese Medicine (SJ-2021-001-04); Ethics review committee of Tianjin Nankai Hospital (NKYY_YX_IRB_2021_002)], with final approval from the group leader at Shenzhen People’s Hospital. Informed consent was obtained from all eligible participants. Consent for publication: Not applicable. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
STARD 2015 flow diagram showing the flow of participants enrolled in the screening trial. FIT fecal immunochemical test, FIT + miR-92a immunochemical fecal occult blood test combined with miR-92a test, AN advanced neoplasia, CRC colorectal cancer
Fig. 2
Fig. 2
Sensitivity and specificity of miR-92a, FIT, and FIT + miR-92a for index lesions observed on colonoscopy. The miR-92a test receiver operating characteristic AUC evaluated CRC (a), AA (b) and AN (c) findings compared with all other findings (medium-risk adenomas, low-risk adenomas, and no findings). AA advanced adenoma, AN advanced neoplasia, AUC area under the curve, CRC colorectal cancer, FIT fecal immunochemical test, FIT + miR-92a immunochemical fecal occult blood test combined with miR-92a test
See this image and copyright information in PMC

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