Urine Metabolomics and Colorectal Cancer Screening

NCT01486745 | Completed

• 2 other identifiers: MTI-2008514
• Study Type: observational
• Target: 2,175
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Polyps

Study Arms (4)

Normal colonoscopy

Colonic polyps

Colorectal cancer patients

Breast & Prostate Cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer

You may qualify if:

• 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

You may not qualify if:

• 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 & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Eisner R, Greiner R, Tso V, Wang H, Fedorak RN. A machine-learned predictor of colonic polyps based on urinary metabolomics. Biomed Res Int. 2013;2013:303982. doi: 10.1155/2013/303982. Epub 2013 Nov 7.

  PMID: 24307992 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Haili Wang, MD FRCS(C)

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2011
• First Posted: December 6, 2011
• Study Start: September 15, 2008
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

CA (1)