NCT01486745

Urine Metabolomics and Colorectal Cancer Screening

Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,175 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-centered study to assess whether urine metabolomics can play a role in the screening of colorectal cancer (CRC). Urine samples will be collected from 1000 patients going through an established CRC screening program, and from a further 500 patients who already have a diagnosis of CRC. Using nuclear magnetic resonance (NMR) spectroscopy, the 1H NMR spectrum of urine samples will be analyzed for specific metabolites, and establish the metabolomic signature of colorectal cancer. The results from metabolomic urinalysis of this screening cohort will be compared with results from colonoscopy, histological descriptions, fecal occult blood testing (FOBT), and fecal immune testing (FIT) to assess the accuracy of urine metabolomics in identifying patients with polyps and malignancies. The urine metabolomic results from the colorectal cancer group will be correlated with operative, histological and clinical staging to define the role of urine metabolomics in assessing colorectal cancer type, location and stage. Additionally approximately 300 urine samples from breast cancer patients and 300 from prostate cancer patients will be collected to validate that the colorectal cancer signature is unique.

Conditions

• Colorectal Cancer
• Colorectal Polyps

Timeline

• Start date: 2008-09-15
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2011-12-06
• Last updated: 2020-04-03

Locations

1 site across 1 country: Canada