Urine Metabolomics and Colorectal Cancer Screening
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ClinicalTrials.gov Identifier: NCT01486745
Recruitment Status : Unknown
Verified May 2016 by Richard Fedorak, University of Alberta. Recruitment status was: Recruiting
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer
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
For screening group:
inflammatory bowel disease
on anticoagulation for reasons other than atrial fibrillation
For Cancer group:
already had neoadjuvant treatment at time of urine collection