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Urine Metabolomics and Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486745
Recruitment Status : Unknown
Verified May 2016 by Richard Fedorak, University of Alberta.
Recruitment status was:  Recruiting
First Posted : December 6, 2011
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Richard Fedorak, University of Alberta

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.

Condition or disease
Colorectal Cancer Colorectal Polyps

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Study Type : Observational
Estimated Enrollment : 1800 participants
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?
Study Start Date : April 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

Biospecimen Retention:   Samples Without DNA
Urine sample

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01486745

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
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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 )
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases