Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Vanderbilt University UCB |
---|---|
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00496548 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 History of Changes |
Health Authority: | United States: Institutional Review Board |
Crohn's Disease |
Dinoprostone Crohn's Disease Digestive System Diseases Gastrointestinal Diseases Ileitis Enteritis |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Ileal Diseases |
Digestive System Diseases Gastrointestinal Diseases Ileitis Enteritis Crohn Disease |
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Ileal Diseases |