Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
|ClinicalTrials.gov Identifier: NCT00496548|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Procedure: Fecal calprotectin Procedure: Urinary PGE-M Level||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Procedure: Fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Procedure: Urinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
- Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ]
- Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ]
- Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ]
- Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496548
|United States, Tennessee|
|GI Clinical Research; Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2285|
|Principal Investigator:||David A. Schwartz, MD||Vanderbilt University|