title: Clinical validation of a novel urine-based metabolomic test for the detection of colonic polyps on Chinese population.
abstract: OBJECTIVE
  Colorectal cancer is the fifth leading cause of cancer-related deaths in China. When detected early, with the removal of adenomatous polyps, precursors of colorectal cancer, it is preventable. The aim of this study was to evaluate a novel urine-based metabolomic diagnostic test for the detection of adenomatous polyps, PolypDx™, that was originally developed and validated using 1000 samples from Canadian Cohort, on Chinese population.
  
  
  METHODS
  Prospective urine samples were collected from 1000 participants undergoing colonoscopy examination, from March 2013 to July 2014 at Minhang District, Shanghai Centre for Disease Control and Prevention. One-dimensional nuclear magnetic resonance spectra of urine metabolites were analyzed to determine the concentrations of three key metabolites used in PolypDx™. The predicted results were then compared to the gold standard for colorectal cancer diagnostic, colonoscopy. Area under curve (AUC) was calculated specifically for the Chinese population and compared with the Canadian dataset. Sensitivity and specificity of this urine-based metabolomic diagnostic test were also compared with three commercially available fecal-based tests.
  
  
  RESULTS
  An AUC of 0.717 for PolypDx™ was calculated on Chinese dataset which is slightly lower than the AUC on the Canadian dataset. A sensitivity of 82.6% and a specificity of 42.4% were achieved on Chinese dataset.
  
  
  CONCLUSIONS
  Here, we validated a novel urine-based metabolomic diagnostic test for the detection of adenomatous polyps, PolypDx™, on Chinese population through a sample size of 1000 participants with a greater level of sensitivity than fecal-based tests.
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada. lu.deng@metabolomictechnologies.ca.
authors.forename: Lu
authors.identifier: http://orcid.org/0000-0002-3324-770X
authors.initials: L
authors.lastname: Deng
authors.affiliation: Shanghai Center for Disease Control and Prevention (CDC), Minhang District, Shanghai, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Fang
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada.
authors.forename: Victor K
authors.initials: VK
authors.lastname: Tso
authors.affiliation: Beijing Genomics Institute (BGI), Shenzhen, Guangdong Province, China.
authors.forename: Yuanyuan
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada.
authors.forename: Rae R
authors.initials: RR
authors.lastname: Foshaug
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada.
authors.forename: Spencer C
authors.initials: SC
authors.lastname: Krahn
authors.affiliation: Shanghai Center for Disease Control and Prevention (CDC), Minhang District, Shanghai, China.
authors.forename: Fen
authors.initials: F
authors.lastname: Zhang
authors.affiliation: Shanghai Center for Disease Control and Prevention (CDC), Minhang District, Shanghai, China.
authors.forename: Yujie
authors.initials: Y
authors.lastname: Yan
authors.affiliation: Shanghai Center for Disease Control and Prevention (CDC), Minhang District, Shanghai, China.
authors.forename: Huilin
authors.initials: H
authors.lastname: Xu
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Chang
authors.affiliation: Beijing Genomics Institute (BGI), Shenzhen, Guangdong Province, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Metabolomic Technologies Inc, Edmonton, AB, Canada.|Department of Medicine, University of Alberta, Edmonton, AB, Canada.
authors.forename: Richard N
authors.initials: RN
authors.lastname: Fedorak
mesh_terms: D000368:Aged; D044466:Asian People; D002681:China; D003111:Colonic Polyps / Q000175:diagnosis / Q000378:metabolism* / Q000652:urine*; D005243:Feces; D005260:Female; D006801:Humans; D008297:Male; D055432:Metabolomics / Q000379:methods*; D012680:Sensitivity and Specificity
keywords: Adenomatous polyps; Colorectal cancer; Metabolomics; PolypDx™; Urine