A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
|ClinicalTrials.gov Identifier: NCT00409396|
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : June 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Procedure: Urinary PGEm level Procedure: fecal calprotectin||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
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.
- Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ]
- Blood for CRP [ Time Frame: Day 1 ]
- Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ]
- MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409396
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||David A. Schwartz, MD||Vanderbilt University Medical Center|