Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cross Cancer Institute at University of Alberta

Haili Wang, MD FRCS(C)

Study Director

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

Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Richard N Fedorak, MD FRCPC	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01486745
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top