Urine Metabolomics and Colorectal Cancer Screening

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Colorectal Polyps Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?

Important dates

Study start: 2008
Primary completion: 2017
Study completion: 2017
First posted: Dec 6, 2011
Registry last updated: Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed