Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
|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 Crohn's Disease Activity|
- Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
- Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ] [ Designated as safety issue: No ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ] [ Designated as safety issue: No ]
- Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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.
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|