Clinical chemistry and laboratory medicine · 2026
A simplified multitarget stool test for colorectal cancer and advanced precancerous lesion detection.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Xu Shuizhi, Gong Lisha, Lu Yibo, Ding Lijian, Mu Rongrong, An Jiamin, Lu Zhuo, Yu Jiayi, Zhu Fangchao, Yang Zhengquan, Huang Dan, Li Jinlei, Wu Xiaoli, Jin Shengnan, Luan Ju, Pan Jie, Xu Chang, Ding Chunming
Аннотация
OBJECTIVES: Multitarget stool tests are approved for colorectal cancer (CRC) screening. Here we developed a multitarget stool test based on the fecal immunochemical test (FIT) and two (NDRG4 and SDC2) DNA methylation markers with a simple calling algorithm.
METHODS: FIT, quantitative methylation-specific PCR for NDRG4 and SDC2 were performed for each participant. A score of either 0, 1 or 2 was assigned to each marker as negative, weak positive and positive. A positive test score was called when the score sum for the three biomarkers was at least 2.
RESULTS: A total of 120 CRC, 23 advanced precancerous lesions (APL) and 308 negative controls (including 59 non-advanced neoplasia, 26 polyps smaller than 10 mm in size and 223 negative colonoscopy) from two hospitals were enrolled. Age-dependent cut-off values were used for FIT and NDRG4 as their levels were positively correlated with age. Sensitivities with the multitarget stool test for CRC and APL were 90.0 % and 65.2 %, respectively, while specificities for participants with negative colonoscopy and absent of advanced neoplasia were 91.0 % and 90.9 %, respectively. We observed a general decline in specificity with more advanced age, which was significantly mitigated by the age-dependent cut-off values.
CONCLUSIONS: The simplified multitarget stool test utilizing age-dependent cut-off values demonstrated promising performance for CRC screening across age groups in the Chinese population.
METHODS: FIT, quantitative methylation-specific PCR for NDRG4 and SDC2 were performed for each participant. A score of either 0, 1 or 2 was assigned to each marker as negative, weak positive and positive. A positive test score was called when the score sum for the three biomarkers was at least 2.
RESULTS: A total of 120 CRC, 23 advanced precancerous lesions (APL) and 308 negative controls (including 59 non-advanced neoplasia, 26 polyps smaller than 10 mm in size and 223 negative colonoscopy) from two hospitals were enrolled. Age-dependent cut-off values were used for FIT and NDRG4 as their levels were positively correlated with age. Sensitivities with the multitarget stool test for CRC and APL were 90.0 % and 65.2 %, respectively, while specificities for participants with negative colonoscopy and absent of advanced neoplasia were 91.0 % and 90.9 %, respectively. We observed a general decline in specificity with more advanced age, which was significantly mitigated by the age-dependent cut-off values.
CONCLUSIONS: The simplified multitarget stool test utilizing age-dependent cut-off values demonstrated promising performance for CRC screening across age groups in the Chinese population.