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NCT00215020 · ClinicalTrials.gov registry record
Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 150
- Enrollment target
NCT00215020 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 150 participants.
The verdict
NCT00215020 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study 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 Children's 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, Crohn's 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00215020
The ClinicalTrials.gov registry entry for NCT00215020 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00215020 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00215020 about?
NCT00215020 is a clinical study titled "Evaluation of Urinary Isoprostanes in the Assessment of Children With Inflammatory Bowel Disease". 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 p...
What is the current status of trial NCT00215020?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2003-09. Estimated completion is 2006-06.
Who is sponsoring clinical trial NCT00215020?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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