Stool-based methylated syndecan-2 test and fecal immunochemical test for advanced colorectal neoplasia screening in the Chinese population: A multicenter randomized noncomparative study.
Colorectal cancer (CRC) is among the most prevalent malignancies, with an increasing incidence in China, posing increasing challenges to current screening strategies. This study aimed to evaluate the feasibility of a screening strategy based on the stool-based methylated Syndecan-2 gene (mSDC2) test for detecting advanced colorectal neoplasia in the Chinese population.
In this multicenter randomized study, participants aged 45-80 years and identified through community screening were randomized to take either the mSDC2 test or a fecal immunochemical test (FIT), and those with positive results were referred for colonoscopy between 2020 and 2022. The primary outcome was the detection rate of advanced colorectal neoplasia, including advanced adenoma, advanced serrated polyps, and CRC. The secondary outcome was adherence to colonoscopy. Univariable and multivariable logistic regression analyses were conducted to evaluate colonoscopy adherence among participants with positive stool-based test results.
A total of 44,475 eligible participants were enrolled from 189 communities (93 in the mSDC2 test group and 96 in the FIT group). In the mSDC2 test group (n = 21,854), the detection rate of advanced neoplasia was 0.53% (n = 115), including 93 (0.43%) advanced adenomas, 8 (0.04%) advanced serrated polyps, and 17 (0.08%) CRC cases. In the FIT group (n = 22,621), the detection rate of advanced neoplasia was 0.47% (n = 106), including 71 (0.31%) advanced adenomas, 9 (0.04%) advanced serrated polyps, and 29 (0.13%) CRC cases. In addition, adherence to colonoscopy was greater in the mSDC2 test group (35.6% vs. 26.4%; odds ratio: 1.59, 95% confidence interval: 1.36-1.87; P <0.001).
This study revealed the effectiveness of the mSDC2 test and FIT in detecting advanced colorectal neoplasia in a large Chinese population in a real-world setting, and indicated a possible improvement in adherence to colonoscopy for the mSDC2 test. Further studies with improved comparability and longer follow-up are warranted to clarify its clinical utility.
ClinicalTrials.gov, No. NCT04221854.
In this multicenter randomized study, participants aged 45-80 years and identified through community screening were randomized to take either the mSDC2 test or a fecal immunochemical test (FIT), and those with positive results were referred for colonoscopy between 2020 and 2022. The primary outcome was the detection rate of advanced colorectal neoplasia, including advanced adenoma, advanced serrated polyps, and CRC. The secondary outcome was adherence to colonoscopy. Univariable and multivariable logistic regression analyses were conducted to evaluate colonoscopy adherence among participants with positive stool-based test results.
A total of 44,475 eligible participants were enrolled from 189 communities (93 in the mSDC2 test group and 96 in the FIT group). In the mSDC2 test group (n = 21,854), the detection rate of advanced neoplasia was 0.53% (n = 115), including 93 (0.43%) advanced adenomas, 8 (0.04%) advanced serrated polyps, and 17 (0.08%) CRC cases. In the FIT group (n = 22,621), the detection rate of advanced neoplasia was 0.47% (n = 106), including 71 (0.31%) advanced adenomas, 9 (0.04%) advanced serrated polyps, and 29 (0.13%) CRC cases. In addition, adherence to colonoscopy was greater in the mSDC2 test group (35.6% vs. 26.4%; odds ratio: 1.59, 95% confidence interval: 1.36-1.87; P <0.001).
This study revealed the effectiveness of the mSDC2 test and FIT in detecting advanced colorectal neoplasia in a large Chinese population in a real-world setting, and indicated a possible improvement in adherence to colonoscopy for the mSDC2 test. Further studies with improved comparability and longer follow-up are warranted to clarify its clinical utility.
ClinicalTrials.gov, No. NCT04221854.
Authors
Chen Chen, Li Li, Gu Gu, Ding Ding, Qin Qin, Pei Pei, Gong Gong, Xu Xu, Liang Liang, Yang Yang, Dou Dou, Huang Huang, Hu Hu, Wu Wu, Zhang Zhang, Wang Wang, Shi Shi, Liu Liu, Li Li, Li Li, Wang Wang, Lan Lan, Liang Liang, He He
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