Clinical and Translational Research
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 28, 2022; 28(24): 2705-2732
Published online Jun 28, 2022. doi: 10.3748/wjg.v28.i24.2705
Novel multiplex stool-based assay for the detection of early-stage colon cancer in a Chinese population
Hui-Hong Jiang, Si-Wei Xing, Xuan Tang, Ying Chen, Kang Lin, Lu-Wei He, Mou-Bin Lin, Er-Jiang Tang
Hui-Hong Jiang, Xuan Tang, Kang Lin, Mou-Bin Lin, Department of General Surgery, Yangpu Hospital, Tongji University, Shanghai 200090, China
Hui-Hong Jiang, Ying Chen, Lu-Wei He, Mou-Bin Lin, Er-Jiang Tang, Institute of Gastrointestinal Surgery and Translational Medicine, Tongji University School of Medicine, Shanghai 200090, China
Si-Wei Xing, Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
Si-Wei Xing, Ying Chen, Kang Lin, Lu-Wei He, Mou-Bin Lin, Er-Jiang Tang, Center for Clinical Research and Translational Medicine, Yangpu Hospital, Tongji University, Shanghai 200090, China
Author contributions: Jiang HH, Xing SW and Lin K performed the experiments; Tang X, Chen Y, and Lin K participated to the collection of the clinical data and samples; Jiang HH, He LW, and Tang EJ analyzed and interpreted the data; Tang EJ, Lin MB and He LW conceived and managed the study; Jiang HH and Xing SW drafted the manuscript; and all authors have read and approve the final manuscript.
Supported by Shanghai Pujiang Program, No. 21PJD066; Shanghai Municipal Commission of Health and Family Planning, No. ZK2019A19; Shanghai Municipal Science and Technology Commission, No. 19411971500; and Shanghai Yangpu District Science and Technology Commission, No. YPM202101.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of Yangpu Hospital, Tongji University (LL-2018-SCI-003).
Clinical trial registration statement: This study was registered at the Chinese Clinical Trial Registry (ChiCTR1800019552).
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Er-Jiang Tang, MSc, Statistician, Center for Clinical Research and Translational Medicine, Yangpu Hospital, Tongji University, No. 450 Tengyue Road, Shanghai 200090, China. tangerjiang1988051@163.com
Received: December 4, 2021
Peer-review started: December 4, 2021
First decision: January 8, 2022
Revised: January 14, 2022
Accepted: May 13, 2022
Article in press: May 13, 2022
Published online: June 28, 2022
Core Tip

Core Tip: Stool DNA (sDNA) methylation analysis has a promising application in the early diagnosis of colorectal cancer. However, reliable biomarkers for detecting early-stage colon cancer (ECC) are lacking. In this study, by targeted bisulfite sequencing, we identified a novel multiplex stool-based assay combining three sDNA methylation biomarkers and fecal immunochemical test. Further validation in larger samples by pyrosequencing showed that it enabled the diagnosis of ECC with high sensitivity and specificity throughout the colon. To our knowledge, this is the first study to focus on ECC screening in China.