Urine Metabolomics and Colorectal Cancer Screening | NCT01486745

Studies
Urine Metabolomics and Colorectal Cancer Screening

NCT01486745

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Apr 3, 2020Actual

Enrollment

2,175Actual

Phase

Not provided

Conditions

Colorectal Cancer
Colorectal Polyps

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
514	Other Identifier	U of A HREB

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2008Actual

Primary Completion Date

Jul 31, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Dec 3, 2011

First Submission Date that Met QC Criteria

Dec 3, 2011

First Posted Date

Dec 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,175Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects undergoing colorectal cancer screening Patients with diagnosis of colorectal cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haili Wang, MD FRCS(C)	University of Alberta	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24307992	Derived	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.

Label	Type	Description	Intervention Names
Normal colonoscopy
Colonic polyps
Colorectal cancer patients
Breast & Prostate Cancer patients

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site