Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial
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 blo...
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2025-06-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Jia-Chen Wang |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7c974f129f0d4e6083a4d367ae69f6ba |
| institution | OA Journals |
| issn | 2054-9369 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Military Medical Research |
| spelling | doaj-art-7c974f129f0d4e6083a4d367ae69f6ba2025-08-20T02:06:28ZengBMCMilitary Medical Research2054-93692025-06-0112111310.1186/s40779-025-00613-3Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trialJia-Chen Wang0Li Zhao1Xiang-Yang Yu2Ting-Ping Wu3Chang-Fa Xia4Ju-Fang Shi5Hui He6Zhi-Qi Chen7Dan Shi8Han Xue9Qi Ao10Shu-Ping Liao11Zhang-Qiang Zheng12Qiong-Fang Huang13Lin Li14Sui-Ling Lin15Ying-Xue Li16Wen-Long Hu17Ji Peng18Lin Lei19Mao-Mao Cao20Fan Yang21Xin-Xin Yan22Si-Yi He23Meng-Di Cao24Shao-Li Zhang25Yi Teng26Qian-Ru Li27Nuo-Pei Tan28Hao-Yang Yu29Hong-Hui Cheng30Xi-Mo Wang31Wei-Qing Wu32Wan-Qing Chen33Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeDepartment 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 TechnologyDepartment of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment of Gastroenterology, Shenzhen Bao’an Traditional Chinese Medicine HospitalOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeDepartment 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 TechnologyDepartment of Nursing, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment 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 TechnologyDepartment of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment 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 TechnologyDepartment of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment 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 TechnologyDepartment of Gastrointestinal Surgery, Tianjin Nankai Hospital, Tianjin Medical UniversityDepartment of Gastroenterology, Shenzhen Bao’an Traditional Chinese Medicine HospitalDepartment of Gastroenterology, Shenzhen People’s Hospital, the Second Clinical Medical College of Jinan University/the First Affiliated Hospital of Southern University of Science and TechnologyClinical Medical Research Center, Shenzhen People’s Hospital, the Second Clinical Medical College of Jinan University/the First Affiliated Hospital of Southern University of Science and TechnologyShenzhen Center for Chronic Disease ControlShenzhen Center for Chronic Disease ControlOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeCollege of Life Sciences and Oceanography, Shenzhen UniversityDepartment of Gastroenterology, Shenzhen Bao’an Traditional Chinese Medicine HospitalTianjin Third Central Hospital, Tianjin Medical UniversityDepartment 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 TechnologyOffice of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeAbstract 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.https://doi.org/10.1186/s40779-025-00613-3Advanced neoplasiaColorectal cancerImmunochemical fecal occult blood testingMiR-92aScreening |
| spellingShingle | 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 Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial Military Medical Research Advanced neoplasia Colorectal cancer Immunochemical fecal occult blood testing MiR-92a Screening |
| title | Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial |
| title_full | Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial |
| title_fullStr | Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial |
| title_full_unstemmed | Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial |
| title_short | Diagnostic efficacy of fecal-based miR-92a for advanced colorectal neoplasia: a prospective multicenter screening trial |
| title_sort | diagnostic efficacy of fecal based mir 92a for advanced colorectal neoplasia a prospective multicenter screening trial |
| topic | Advanced neoplasia Colorectal cancer Immunochemical fecal occult blood testing MiR-92a Screening |
| url | https://doi.org/10.1186/s40779-025-00613-3 |
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