Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical
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RESEARCH
Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study Jianping Wang1*, Side Liu2*, Hui Wang1, Lei Zheng3, Changchun Zhou4, Guoxin Li5, Rongkang Huang1, Huaiming Wang1, Chujun Li6, Xinjuan Fan7, Xinhui Fu8, Xinying Wang9, Hongliang Guo10, Jie Guan10, Yanlai Sun10, Xilin Song10, Zengjun Li11, Dianbin Mu12, Jujie Sun12, Xianglin Liu13, Yan Qi13, Feng Niu13, Chunhua Chen13, Xiaolin Wu13, Xianshu Wang13, Xianrang Song4* and Hongzhi Zou1,13*
Abstract Background and Aims: Stool DNA testing is an emerging and attractive option for colorectal cancer (CRC) screening. We previously evaluated the feasibility of a stool DNA (sDNA) test of methylated SDC2 for CRC detection. The aim of this study was to assess its performance in a multicenter clinical trial setting. Methods: Each participant was required to undergo a sDNA test and a reference colonoscopy. The sDNA test consists of quantitative assessment of methylation status of SDC2 promoter. Results of real-time quantitative methylationspecific PCR were dichotomized as positive and negative, and the main evaluation indexes were sensitivity, specificity, and kappa value. All sDNA tests were performed and analyzed independently of colonoscopy. Results: Among the 1110 participants from three clinical sites analyzed, 359 and 38 were diagnosed, respectively, with CRC and advanced adenomas by colonoscopy. The sensitivity of the sDNA test was 301/359 (83.8%) for CRC, 16/38 (42.1%) for advanced adenomas, and 134/154 (87.0%) for early stage CRC (stage I–II). Detection rate did not vary significantly according to age, tumor location, differentiation, and TNM stage, except for gender. The follow-up testing of 40 postoperative patients with CRC returned negative results as their tumors had been surgically removed. The specificity of the sDNA test was 699/713 (98.0%), and unrelated cancers and diseases did not seem to interfere with the testing. The kappa value was 0.84, implying an excellent diagnostic consistency between the sDNA test and colonoscopy.
*Correspondence: [email protected]; [email protected]; [email protected]; [email protected] 1 Department of Colorectal Surgery, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, , Sun Yat-Sen University, Yuancun Erheng Road, Guangzhou 510655, Guangdong, China 2 Department of Gastroenterology, Nanfang Hospital, Southern Medical University, 1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 4 Clinical Laboratory, Shandong Provincial Key Laboratory of Cancer Radiation, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Sciences, 440 Jiyan Road, Jinan, Shandong, China Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptatio
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