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Background <p>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.</p> Methods <p>Overall, 16,240 participants aged 30–75&#xa0;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.</p> Results <p>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% (<i>P</i> &lt; 0.001), NNS was 24.7 versus 32.2 (<i>P</i> = 0.001), Youden index was 47.9% versus 35.0% (<i>P</i> &lt; 0.001), AUC was 0.74 versus 0.67 (<i>P</i> = 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.</p> Conclusions <p>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.</p> <i>Trial registration</i> <p>Chinese Clinical Trial Registration Number: ChiCTR2200065415.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月13日

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  • 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

摘要

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.