NCT00409396

A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.

Detailed description

The available clinical measures of ulcerative colitis 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 UC 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. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
PROCEDURE	Urinary PGEm level	Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
PROCEDURE	fecal calprotectin	Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2006-12-08
• Last updated: 2015-06-09

Locations

1 site across 1 country: United States