Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215020
Status:
COMPLETED
Last Update Posted:
2016-01-27
First Post:
2005-09-15
Brief Title:
Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Phase I Evaluation of Urinary Isoprostane Levels in Pediatric Patients With Inflammatory and Non-Inflammatory Gastrointestinal Disease
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Isoprostanes are compounds that are produced as a result of oxidative damage to cell membranes Elevated tissue serum and urinary isoprostane levels have been described in a number of inflammatory diseases The goal of this study is to determine utility of measuring urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory gastrointestinal disease Urine samples will be collected from pediatric patients undergoing procedures in the Childrens Hospital endoscopy unit Clinical disease activity will be assessed using a standardized clinical disease activityiIndex Gross endoscopic and histologic findings will be graded Previously obtained laboratory studies will also be recorded Urinary Isoprostane levels will be determined using a commercially available assay Isoprostane levels will be compared across conditions IBD vs non-inflammatory Crohns disease vs ulcerative colitis and tested for statistical significance Similarly disease severity and urinary isoprostane levels will be assessed The sensitivity specificity and positive and negative predictive values of elevated urinary isoprostane levels at discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal disease will be calculated
Detailed Description:
Isoprostanes are compounds produced as a result of oxidative damage to cell membranes Elevated tissue serum and urinary isoprostane levels have been described in a number of inflammatory diseases The goal of this study is to determine utility of measuring urinary isoprostane levels in pediatric patients with inflammatory and non-inflammatory gastrointestinal disease Urine samples will be collected from pediatric patients undergoing procedures in the Childrens Hospital endoscopy unit Clinical disease activity will be assessed using a standardized clinical disease activityiIndex Gross endoscopic and histologic findings will be graded Previously obtained laboratory studies will also be recorded Urinary Isoprostane levels will be determined using a commercially available assay Isoprostane levels will be compared across conditions IBD vs non-inflammatory Crohns disease vs ulcerative colitis and tested for statistical significance Similarly disease severity and urinary isoprostane levels will be assessed The sensitivity specificity and positive and negative predictive values of elevated urinary isoprostane levels at discriminating pediatric patients with inflammatory and non-inflammatory gastrointestinal disease will be calculated
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