Urine Metabolomics and Colorectal Cancer Screening

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT01486745

Collaborator

(none)

2,175

Enrollment

Location

106.5

Actual Duration (Months)

20.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Polyps

Study Design

Study Type:

Observational

Actual Enrollment :

2175 participants

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?

Actual Study Start Date :

Sep 15, 2008

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada

Sponsors and Collaborators

University of Alberta

Investigators

Study Director: Haili Wang, MD FRCS(C), University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT01486745

Other Study ID Numbers:

MTI-2008
514

First Posted:

Dec 6, 2011

Last Update Posted:

Apr 3, 2020

Last Verified:

Apr 1, 2020

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 3, 2020