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Urine Metabolomics and Colorectal Cancer Screening

This study is currently recruiting participants.
Verified May 2016 by Richard Fedorak, University of Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486745
First Posted: December 6, 2011
Last Update Posted: May 13, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Fedorak, University of Alberta
  Purpose
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
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)
Groups/Cohorts
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

  Eligibility

Information from the National Library of Medicine

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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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01486745


Contacts
Contact: Haili Wang, MD FRCS(C) (647) 458-7452 haili@ualberta.ca

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Fedorak, Proffesor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01486745     History of Changes
Other Study ID Numbers: MTI-2008
514 ( Other Identifier: U of A HREB )
First Submitted: December 3, 2011
First Posted: December 6, 2011
Last Update Posted: May 13, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases