A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|