Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
|ClinicalTrials.gov Identifier: NCT00496548|
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Procedure: Fecal calprotectin Procedure: Urinary PGE-M Level||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Procedure: Fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.Procedure: Urinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
- Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ]
- Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ]
- Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ]
- Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496548
|United States, Tennessee|
|GI Clinical Research; Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2285|
|Principal Investigator:||David A. Schwartz, MD||Vanderbilt University|