1. Fecal Clostridium symbiosum for Noninvasive Detection of Early and Advanced Colorectal Cancer: Test and Validation Studies
- Author
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Yuan-Hong Xie, Qin-Yan Gao, Guo-Xiang Cai, Xiao-Ming Sun, Tian-Hui Zou, Hui-Min Chen, Si-Yi Yu, Yi-Wen Qiu, Wei-Qi Gu, Xiao-Yu Chen, Yun Cui, Danfeng Sun, Zhan-Ju Liu, San-Jun Cai, Jie Xu, Ying-Xuan Chen, and Jing-Yuan Fang
- Subjects
Colorectal cancer ,Early diagnosis ,Clostridium symbiosum ,Quantitative PCR ,Medicine ,Medicine (General) ,R5-920 - Abstract
Objective: Current non-invasive early detection of colorectal cancer (CRC) requires improvement. We aimed to identified a fecal Clostridium symbiosum-based biomarker for early and advanced colorectal cancer detection. Design: In the test stage, the relative abundance of Clostridium symbiosum (C. symbiosum) was measured by qPCR in 781 cases including 242 controls, 212 colorectal adenoma (CRA) patients, 109 early CRC (tumor restricted to the submucosa) patients, 218 advanced CRC patients. The prediction accuracy was compared to Fusobacterium nucleatum (F. nucleatum), fecal immunochemical test (FIT) and CEA (carcinoembryonic antigen) and validated in an independent cohort of 256 subjects. Current status of the trial:ongoing/still enrolling. Primary endpoint:June, 2017 (Clinicaltrials.gov Identifier NCT02845973). Results: Significant stepwise increase of C. symbiosum abundance was found in CRA, early CRC and advanced CRC (P
- Published
- 2017
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