Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt University
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00496548
First received: July 2, 2007
Last updated: May 6, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Crohn's Disease |
Procedure: Fecal calprotectin Procedure: Urinary PGE-M Level |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ] [ Designated as safety issue: No ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ] [ Designated as safety issue: No ]
- Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496548
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496548
Locations
| United States, Tennessee | |
| GI Clinical Research; Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232-2285 | |
Sponsors and Collaborators
Vanderbilt University
UCB Pharma
Investigators
| Principal Investigator: | David A. Schwartz, MD | Vanderbilt University |
More Information
| Responsible Party: | David Schwartz, Principal Investigator, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00496548 History of Changes |
| Other Study ID Numbers: | Urinary PGE-M CD |
| Study First Received: | July 2, 2007 |
| Last Updated: | May 6, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Crohn's Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on September 30, 2016