Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409396
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2006-12-05
Brief Title:
A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Urinary PGE-M A Metabolite of PGE2 A Novel Biomarker of Ulcerative Colitis Disease
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin
Detailed Description:
The available clinical measures of ulcerative colitis 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 UC 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 We recently showed that PGEm was a sensitive and specific marker of Crohns disease activity Accepted for publication at DDW 2006
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 We recently showed that PGEm was a sensitive and specific marker of Crohns disease activity Accepted for publication at DDW 2006
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None