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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
UCB Pharma
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00496548
First received: July 2, 2007
Last updated: June 23, 2010
Last verified: June 2010
History of Changes
  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: 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 Crohn's Disease Activity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ] [ Designated as safety issue: No ]
  • Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ] [ Designated as safety issue: No ]
  • Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ] [ Designated as safety issue: No ]
Estimated Enrollment: 30
Study Start Date: August 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00496548

Locations
United States, Tennessee
GI Clinical Research; Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2285
Sponsors and Collaborators
Vanderbilt University
UCB Pharma
Investigators
Principal Investigator: David A. Schwartz, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: David A Schwartz, MD, VUMC
ClinicalTrials.gov Identifier: NCT00496548     History of Changes
Other Study ID Numbers: Urinary PGE-M CD
Study First Received: July 2, 2007
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Crohn's Disease

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

ClinicalTrials.gov processed this record on March 03, 2015