Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Vanderbilt University.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

UCB, Inc.

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00496548

First received: July 2, 2007

Last updated: June 23, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2007

Last Updated Date

June 23, 2010

Start Date ^ICMJE

August 2007

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Urine for PGEm levels at clinic visit when colonoscopy is scheduled
Routine colonoscopy for assessment of disease activity
Mayo disease activity score at time of colonoscopy

Change History

Complete list of historical versions of study NCT00496548 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ] [ Designated as safety issue: No ]
Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ] [ Designated as safety issue: No ]
Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Blood for CRP at clinic visit when colonoscopy is scheduled
Stool for fecal calprotectin at clinic visit when colonoscopy is scheduled

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

Official Title ^ICMJE

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity

Brief Summary

The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.

Detailed Description

The available clinical measures of Crohn's disease activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, C-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. What is needed is a simple, non-invasive, biologic measure of Crohn's disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Procedure: Fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Procedure: Urinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Study Arm (s)

Experimental: 1

Fecal calprotectin and urinary PGE-M levels will be tested on all participants.

Interventions:

Procedure: Fecal calprotectin
Procedure: Urinary PGE-M Level

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2011

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Outpatient male or female 18 years or older
Confirmed diagnosis of Crohn's disease
Informed consent obtained
Able to give blood, urine and stool samples
Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care

Exclusion Criteria:

Unable to give consent
Ulcerative colitis
Does not meet inclusion criteria
Pregnant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00496548

Other Study ID Numbers ^ICMJE

Urinary PGE-M CD

Has Data Monitoring Committee

Yes

Responsible Party

David A Schwartz, MD, VUMC

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

UCB, Inc.

Investigators ^ICMJE

Principal Investigator:

David A. Schwartz, MD

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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