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Clinical Trials/NCT01486745
NCT01486745
Completed
Not Applicable

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

University of Alberta1 site in 1 country2,175 target enrollmentSeptember 15, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of Alberta
Enrollment
2175
Locations
1
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 15, 2008
End Date
July 31, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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