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| Sponsors and Collaborators: |
Vanderbilt University UCB |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00496548 |
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: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kelly L. Shields | 615-343-8854 | kelly.shields@vanderbilt.edu |
| Contact: Kathy Price, RN, MBA | 615-322-4643 | kathy.price@vanderbilt.edu |
| United States, Tennessee | |
| GI Clinical Research; Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232-2285 | |
| Contact: Kelly Shields 615-343-8854 kelly.shields@vanderbilt.edu | |
| Principal Investigator: David A. Schwartz, MD | |
| Principal Investigator: | David A. Schwartz, MD | Vanderbilt University |
More Information
| Responsible Party: | VUMC ( David A Schwartz, MD ) |
| Study ID Numbers: | Urinary PGE-M CD |
| Study First Received: | July 2, 2007 |
| Last Updated: | November 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00496548 |
| Health Authority: | United States: Institutional Review Board |
|
Crohn's Disease |
|
Dinoprostone Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
