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A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
This study has been completed.
Sponsor:
Vanderbilt University
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00409396
First received: December 5, 2006
Last updated: June 5, 2015
Last verified: November 2014
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Purpose
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.
| Condition | Intervention |
|---|---|
| Ulcerative Colitis | Procedure: Urinary PGEm level Procedure: fecal calprotectin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease |
Resource links provided by NLM:
Further study details as provided by David Schwartz, Vanderbilt University:
Primary Outcome Measures:
- Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ]
Secondary Outcome Measures:
- Blood for CRP [ Time Frame: Day 1 ]
- Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ]
- MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ]
| Enrollment: | 35 |
| Study Start Date: | November 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Fecal calprotectin and urinary PGEm levels will be tested on all participants.
|
Procedure: Urinary PGEm level
Level of PGEm in urine compared to CRP and fecal calprotectin levels in patients with ulcerative colitis.
Procedure: fecal calprotectin
Level of fecal calprotectin in comparison to urinary PGEm and serum CRP levels.
|
Detailed Description:
The available clinical measures of ulcerative colitis 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 UC 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. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Outpatient male or female 18 years or older
- Confirmed diagnosis of ulcerative colitis
- Informed consent obtained
- Able to give blood, urine and stool samples
- Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care
Exclusion Criteria:
- Unable to give consent
- Crohn's disease
- Does not meet inclusion criteria
- Pregnant
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00409396
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409396
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
Procter and Gamble
Investigators
| Principal Investigator: | David A. Schwartz, MD | Vanderbilt University Medical Center |
More Information
| Responsible Party: | David Schwartz, Principal Investigator, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00409396 History of Changes |
| Other Study ID Numbers: |
Urinary PGE-M UC |
| Study First Received: | December 5, 2006 |
| Last Updated: | June 5, 2015 |
Keywords provided by David Schwartz, Vanderbilt University:
|
Ulcerative Colitis PGE-M fecal calprotectin disease biomarkers |
Additional relevant MeSH terms:
|
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
ClinicalTrials.gov processed this record on August 22, 2017