Clinical trial NCT01486745: Urine Metabolomics and Colorectal Cancer Screening
Official title: Is There a Role for Using NMR Urine Metabolomics as a New Method of Screening for Colorectal Cancer?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colorectal Polyps
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 2175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Haili Wang, MD FRCS(C)
role: STUDY_DIRECTOR
References:
citation: 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.