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 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 Ulcerative Colitis Disease |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Urine for PGEm Levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood for CRP [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- Stool for fecal calprotectin [ Time Frame: At least 2 days before colonoscopy procedure (prior to bowel prep) ] [ Designated as safety issue: No ]
- MAYO disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
- Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks after consent ] [ Designated as safety issue: No ]
| 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) |
| Genders Eligible for Study: | Both |
| 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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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: 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 |
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 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 September 26, 2016