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Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

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ClinicalTrials.gov Identifier: NCT00496548
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Crohn's Disease Procedure: Fecal calprotectin Procedure: Urinary PGE-M Level Not Applicable

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 inflammatory bowel disease (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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
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 Crohn's Disease Activity
Study Start Date : August 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ]

Secondary Outcome Measures :
  1. Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ]
  2. Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ]
  3. Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ]
  4. Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ]

Eligibility Criteria
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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 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496548


Locations
United States, Tennessee
GI Clinical Research; Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2285
Sponsors and Collaborators
Vanderbilt University Medical Center
UCB Pharma
Investigators
Principal Investigator: David A. Schwartz, MD Vanderbilt University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: David Schwartz, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00496548     History of Changes
Other Study ID Numbers: Urinary PGE-M CD
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Schwartz, Vanderbilt University Medical Center:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases