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

This study has been completed.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
David Schwartz, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00496548
First received: July 2, 2007
Last updated: April 30, 2017
Last verified: April 2017
July 2, 2007
April 30, 2017
August 2007
December 2015   (Final data collection date for primary outcome measure)
Urine for PGE-M levels [ Time Frame: Day of colonoscopy procedure ]
  • Routine colonoscopy for assessment of disease activity
  • Mayo disease activity score at time of colonoscopy
  • Urine for PGEm levels at clinic visit when colonoscopy is scheduled
Complete list of historical versions of study NCT00496548 on ClinicalTrials.gov Archive Site
  • Blood for C-reactive protein (CRP) levels [ Time Frame: Day 1 ]
  • Stool for fecal calprotectin [ Time Frame: Prior to colonoscopy procedure (before beginning bowel prep) ]
  • Routine colonoscopy for assessment of disease activity [ Time Frame: 1-3 weeks from consent ]
  • Harvey-Bradshaw index disease activity score [ Time Frame: Day of colonoscopy procedure ]
  • Blood for CRP at clinic visit when colonoscopy is scheduled
  • Stool for fecal calprotectin at clinic visit when colonoscopy is scheduled
Not Provided
Not Provided
 
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Crohn's Disease
  • 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.
Experimental: 1
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Interventions:
  • Procedure: Fecal calprotectin
  • Procedure: Urinary PGE-M Level
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00496548
Urinary PGE-M CD
Yes
Not Provided
Plan to Share IPD: No
David Schwartz, Vanderbilt University Medical Center
Vanderbilt University Medical Center
UCB Pharma
Principal Investigator: David A. Schwartz, MD Vanderbilt University
Vanderbilt University Medical Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP