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Trial record 1 of 1 for:    NCT01486745
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Urine Metabolomics and Colorectal Cancer Screening

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Richard Fedorak, University of Alberta
Information provided by (Responsible Party):
Richard Fedorak, University of Alberta Identifier:
First received: December 3, 2011
Last updated: May 12, 2016
Last verified: May 2016
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.

Colorectal Cancer Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

Resource links provided by NLM:

Further study details as provided by Richard Fedorak, University of Alberta:

Biospecimen Retention:   Samples Without DNA
Urine sample

Estimated Enrollment: 1800
Study Start Date: April 2008
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01486745

Contact: Haili Wang, MD FRCS(C) (647) 458-7452

Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Richard N Fedorak, MD FRCPC         
Sponsors and Collaborators
University of Alberta
Study Director: Haili Wang, MD FRCS(C) University of Alberta
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard Fedorak, Proffesor of Medicine, University of Alberta Identifier: NCT01486745     History of Changes
Other Study ID Numbers: MTI-2008
514 ( Other Identifier: U of A HREB )
Study First Received: December 3, 2011
Last Updated: May 12, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases processed this record on September 21, 2017