Urine Metabolomics and Colorectal Cancer Screening

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colorectal Polyps

• Study Type: Observational
• Enrollment (Actual): 2175

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer

Description

Inclusion Criteria:

For Screening group (normal colonoscopy & colonic polyps):

• asymptomatic, 50-75 year old, without personal or family history of CRC/polyps
• asymptomatic, 40-75 year old, known personal or first-degree family history of either CRC or polyps

For Cancer group:

• any patient with diagnosis of colorectal cancer
• any patient with diagnosis of prostate cancer
• any patient with diagnosis of breast cancer

Exclusion Criteria:

For screening group:

• hematochezia
• inflammatory bowel disease
• on anticoagulation for reasons other than atrial fibrillation
• significant co-morbidities

For Cancer group:

• already had neoadjuvant treatment at time of urine collection
• no invasive cancer at time of urine collection

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Study Director: Haili Wang, MD FRCS(C), University of Alberta

Publications and helpful links

General Publications

• Eisner R, Greiner R, Tso V, Wang H, Fedorak RN. A machine-learned predictor of colonic polyps based on urinary metabolomics. Biomed Res Int. 2013;2013:303982. doi: 10.1155/2013/303982. Epub 2013 Nov 7.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2008
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: December 3, 2011
• First Submitted That Met QC Criteria: December 3, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MTI-2008; 514 (Other Identifier: U of A HREB)