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Urine Metabolomics and Colorectal Cancer Screening

This study is currently recruiting participants.
Verified December 2011 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Richard Fedorak, University of Alberta
ClinicalTrials.gov Identifier:
NCT01486745
First received: December 3, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Biospecimen Retention:   Samples Without DNA

Urine sample


Estimated Enrollment: 1800
Study Start Date: April 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Fedorak, Proffesor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT01486745     History of Changes
Other Study ID Numbers: MTI-2008, 514
Study First Received: December 3, 2011
Last Updated: December 3, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013