Urine Metabolomics and Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486745
• Other study ID #: MTI-2008
• Secondary ID: 514
• Status: Completed
• Start date: September 15, 2008
• Est. completion date: July 31, 2017

Study information

• Verified date: April 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2175
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyps

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada,