A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Procedure: Urinary PGEm level
* Procedure: fecal calprotectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient male or female 18 years or older Confirmed diagnosis of ulcerative colitis Informed consent obtained Able to give blood, urine and stool samples Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care Exclusion Criteria: Unable to give consent Crohn's disease Does not meet inclusion criteria Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fecal calprotectin and urinary PGEm levels will be tested on all participants. | Procedure: Urinary PGEm level<br>* Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.<br>Procedure: fecal calprotectin<br>* Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine for PGEm Levels |  | Day of colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Day of colonoscopy procedure | 
| Routine colonoscopy for assessment of disease activity |  | 1-3 weeks after consent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative, Colitis, PGE-M, fecal calprotectin, disease biomarkers