Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | July 2, 2007 | ||||
Last Updated Date | June 23, 2010 | ||||
Start Date ICMJE | August 2007 | ||||
Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00496548 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity | ||||
Official Title ICMJE | Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity | ||||
Brief Summary | 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. |
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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 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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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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Condition ICMJE | Crohn's Disease | ||||
Intervention ICMJE |
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Study Arm (s) | Experimental: 1
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 30 | ||||
Estimated Completion Date | February 2011 | ||||
Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00496548 | ||||
Other Study ID Numbers ICMJE | Urinary PGE-M CD | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | David A Schwartz, MD, VUMC | ||||
Study Sponsor ICMJE | Vanderbilt University | ||||
Collaborators ICMJE | UCB, Inc. | ||||
Investigators ICMJE |
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Information Provided By | Vanderbilt University | ||||
Verification Date | June 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |