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

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Procedure: Fecal calprotectin; Procedure: Urinary PGE-M Level

• Registration Number: NCT00496548
• Lead Sponsor: Vanderbilt University Medical Center

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 inflammatory bowel disease (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 Timeline

• Study First Submitted: 2007-07-02
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Study Start: 2007-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-30
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fecal calprotectin	Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
1	Urinary PGE-M Level	Fecal calprotectin and urinary PGE-M levels will be tested on all participants.

Primary Outcome Measures

Name	Time	Method
Urine for PGE-M levels	Day of colonoscopy procedure

Secondary Outcome Measures

Name	Time	Method
Harvey-Bradshaw index disease activity score	Day of colonoscopy procedure
Blood for C-reactive protein (CRP) levels	Day 1
Routine colonoscopy for assessment of disease activity	1-3 weeks from consent
Stool for fecal calprotectin	Prior to colonoscopy procedure (before beginning bowel prep)

Trial Locations

Locations (1)

GI Clinical Research; Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States