Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal calprotectin
Urinary PGE-M Level
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn's Disease focused on measuring Crohn's Disease
Eligibility 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
Sites / Locations
- GI Clinical Research; Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Outcomes
Primary Outcome Measures
Urine for PGE-M levels
Secondary Outcome Measures
Blood for C-reactive protein (CRP) levels
Stool for fecal calprotectin
Routine colonoscopy for assessment of disease activity
Harvey-Bradshaw index disease activity score
Full Information
NCT ID
NCT00496548
First Posted
July 2, 2007
Last Updated
April 30, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
UCB Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00496548
Brief Title
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
Official Title
Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Fecal calprotectin and urinary PGE-M levels will be tested on all participants.
Intervention Type
Procedure
Intervention Name(s)
Fecal calprotectin
Intervention Description
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
Intervention Type
Procedure
Intervention Name(s)
Urinary PGE-M Level
Intervention Description
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.
Primary Outcome Measure Information:
Title
Urine for PGE-M levels
Time Frame
Day of colonoscopy procedure
Secondary Outcome Measure Information:
Title
Blood for C-reactive protein (CRP) levels
Time Frame
Day 1
Title
Stool for fecal calprotectin
Time Frame
Prior to colonoscopy procedure (before beginning bowel prep)
Title
Routine colonoscopy for assessment of disease activity
Time Frame
1-3 weeks from consent
Title
Harvey-Bradshaw index disease activity score
Time Frame
Day of colonoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Schwartz, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GI Clinical Research; Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2285
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity
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