The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
159
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
GI Clinical Research; Vanderbilt University Medical Center
Nashville, Tennessee, United States
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
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