A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
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.
Procedure: Urinary PGEm level
Procedure: fecal calprotectin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease|
- Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
- Blood for CRP [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ] [ Designated as safety issue: No ]
- MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409396
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||David A. Schwartz, MD||Vanderbilt University|