Clinical validation of a novel urine-based metabolomic test for the detection of colonic polyps on Chinese population

Abstract

Purpose

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.

This is a preview of subscription content, log in to check access.

References

  1. 1.

    Liu S, Zheng R, Zhang M, Zhang S, Sun X, Chen W (2015) Incidence and mortality of colorectal cancer in China, 2011. Chin J Cancer Res 27(1):22–28. doi:10.3978/j.issn.1000-9604.2015.02.01

    Article  PubMed  PubMed Central  Google Scholar 

  2. 2.

    Leddin DJ, Enns R, Hilsden R, Plourde V, Rabeneck L, Sadowski DC, Signh H (2010) Canadian Association of Gastroenterology position statement on screening individuals at average risk for developing colorectal cancer: 2010. Can J Gastroenterol 24(12):705–714

    Article  PubMed  PubMed Central  Google Scholar 

  3. 3.

    Taylor DP, Cannon-Albright LA, Sweeney C, Williams MS, Haug PJ, Mitchell JA, Burt RW (2011) Comparison of compliance for colorectal cancer screening and surveillance by colonoscopy based on risk. Genet Med 13(8):737–743. doi:10.1097/GIM.0b013e3182180c71

    Article  PubMed  Google Scholar 

  4. 4.

    Eisner R, Greiner R, Tso V, Wang H, Fedorak RN (2013) A machine-learned predictor of colonic polyps based on urinary metabolomics. Biomed Res Int 2013:303982. doi:10.1155/2013/303982

    Article  PubMed  PubMed Central  Google Scholar 

  5. 5.

    Wong CK, Fedorak RN, Prosser CI, Stewart ME, van Zanten SV, Sadowski DC (2012) The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. Int J Color Dis 27(12):1657–1664. doi:10.1007/s00384-012-1518-3

    Article  Google Scholar 

  6. 6.

    Wang H, Tso V, Wong C, Sadowski D, Fedorak RN (2014) Development and validation of a highly sensitive urine-based test to identify patients with colonic adenomatous polyps. Clin Transl Gastroenterol 5:e54. doi:10.1038/ctg.2014.2

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Lu Deng.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Conflict of interest

R.N.F. is the co-founder and majority shareholder; L.D., V.K.T., R.R.F., S.C.K., and D.C. are employees of the Metabolomic Technologies Inc. (MTI). MTI is commercializing the PolypDx™.

Electronic supplementary material

ESM 1

(DOCX 1339 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Deng, L., Fang, H., Tso, V.K. et al. Clinical validation of a novel urine-based metabolomic test for the detection of colonic polyps on Chinese population. Int J Colorectal Dis 32, 741–743 (2017). https://doi.org/10.1007/s00384-016-2729-9

Download citation

Keywords

  • Colorectal cancer
  • Adenomatous polyps
  • Metabolomics
  • Urine
  • PolypDx™