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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fecal calprotectin and urinary PGEm levels will be tested on all participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary PGEm level | Procedure | Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine for PGEm Levels | Day of colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Blood for CRP | Day 1 | |
| Stool for fecal calprotectin | At least 2 days before colonoscopy procedure (prior to bowel prep) | |
| MAYO disease activity score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A. Schwartz, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D014456 | Ulcer |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
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| fecal calprotectin | Procedure | Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels. |
|
| Day of colonoscopy procedure |
| Routine colonoscopy for assessment of disease activity | 1-3 weeks after consent |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |