- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00496548
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-2285
- GI Clinical Research; Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine for PGE-M levels
Time Frame: Day of colonoscopy procedure
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Day of colonoscopy procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Blood for C-reactive protein (CRP) levels
Time Frame: Day 1
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Day 1
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Stool for fecal calprotectin
Time Frame: Prior to colonoscopy procedure (before beginning bowel prep)
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Prior to colonoscopy procedure (before beginning bowel prep)
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Routine colonoscopy for assessment of disease activity
Time Frame: 1-3 weeks from consent
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1-3 weeks from consent
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Harvey-Bradshaw index disease activity score
Time Frame: Day of colonoscopy procedure
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Day of colonoscopy procedure
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David A. Schwartz, MD, Vanderbilt University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Urinary PGE-M CD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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