Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

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 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.

Detailed Description
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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.

Official Title
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Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity

Conditions
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Crohn's Disease

Intervention / Treatment
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* Procedure: Fecal calprotectin
* Procedure: Urinary PGE-M Level


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 Crohn's disease Informed consent obtained Able to give blood, urine and stool samples Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care Exclusion Criteria: Unable to give consent Ulcerative colitis 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fecal calprotectin and urinary PGE-M levels will be tested on all participants. | Procedure: Fecal calprotectin<br>* Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.<br>Procedure: Urinary PGE-M Level<br>* Urinary PGE-M level obtained and compared to fecal calprotectin 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 PGE-M levels |  | Day of colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 1-3 weeks from consent | 
| Harvey-Bradshaw index disease activity score |  | Day of colonoscopy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease