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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fecal calprotectin and urinary PGE-M levels will be tested on all participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal calprotectin | Procedure | Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine for PGE-M levels | Day of colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Blood for C-reactive protein (CRP) levels | Day 1 | |
| Stool for fecal calprotectin | Prior to colonoscopy procedure (before beginning bowel prep) | |
| Routine colonoscopy for assessment of disease activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A. Schwartz, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Clinical Research; Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2285 | United States |
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| Urinary PGE-M Level | Procedure | Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels. |
|
| 1-3 weeks from consent |
| Harvey-Bradshaw index disease activity score | Day of colonoscopy procedure |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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