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

Crohn's Disease Clinical Trial

Official title:

Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Crohn's Disease Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496548
• Other study ID #: Urinary PGE-M CD
• Status: Completed
• Phase: N/A
• First received: July 2, 2007
• Last updated: April 30, 2017
• Start date: August 2007
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Procedure:
• Fecal calprotectin
Fecal calprotectin levels obtained and compared to urinary PGE-M and serum C-reactive protein (CRP) levels.
• Urinary PGE-M Level
Urinary PGE-M level obtained and compared to fecal calprotectin and serum CRP levels.

Locations

Country	Name	City	State
United States	GI Clinical Research; Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine for PGE-M levels		Day of colonoscopy procedure
Secondary	Blood for C-reactive protein (CRP) levels		Day 1
Secondary	Stool for fecal calprotectin		Prior to colonoscopy procedure (before beginning bowel prep)
Secondary	Routine colonoscopy for assessment of disease activity		1-3 weeks from consent
Secondary	Harvey-Bradshaw index disease activity score		Day of colonoscopy procedure