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NCT00598455 · ClinicalTrials.gov registry record
Tuberous Sclerosis Complex Natural History Study: Renal Manifestations
A clinical trial of Tuberous Sclerosis Complex, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 450
- Enrollment target
- 1
- Study location
NCT00598455 is a study of Tuberous Sclerosis Complex that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 450 participants, above the 101-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (346% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00598455, a study of Tuberous Sclerosis Complex, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 450 participants
- Enrollment target
- 1
- Study location
Study Summary
Eighty percent of patients with tuberous sclerosis complex (TSC) have renal angiomyolipomata. These lesions grow and can lead to significant morbidity by hemorrhage or renal failure. Understanding the natural history of these lesions and understanding which lesions may be more prone to grow quickly or develop aneurysms that predispose to hemorrhage will greatly assist clinical care of patients with TSC. The objective is to test the hypothesis that serial MR and CT imaging will allow objective, reproducible quantification of angiomyolipoma growth by volumetric analysis, and analysis of lesions characteristics will identify angiomyolipomata with rapid growth potential that would require intervention. The specific aim of this proposal is to collect clinically obtained serial abdominal imaging from the Tuberous Sclerosis Natural History Consortium Centers and analyze the volume and adiposity of the individual angiomyolipomata. The growth rate is hypothesized to have an inverse relationship to adiposity. Yearly renal MR or CT imaging will be performed of patients with TSC. The images will be coded at the site of acquisition, and transferred via VPN to a secure server at Cincinnati Children's Hospital Medical Center. Using innovative imaging processing software (Cincinnati Children's Hospital Image Processing Software (CCHIPS), the image data will be segmented to reveal various tissue components based on signal intensities. Different signal intensities can differentiate normal renal parenchyma, and renal angiomyolipomata. Using the imaging data and the novel software, the volume of an individual angiomyolipoma, as well as the adiposity will be determined. Imaging at enrollment (year 1) will serve as baseline. At years two and three, the lesions will undergo repeat analysis. Angiomyolipoma growth rates and adiposity over three years will be analyzed to test the hypothesis above.
Conditions Studied
Study Locations (1)
Ohio
- Cincinnati Children's - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00598455
The ClinicalTrials.gov registry entry for NCT00598455 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (346% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 0 interventions.
NCT00598455 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00598455 about?
NCT00598455 is a clinical study titled "Tuberous Sclerosis Complex Natural History Study: Renal Manifestations". Eighty percent of patients with tuberous sclerosis complex (TSC) have renal angiomyolipomata. These lesions grow and can lead to significant morbidity by hemorrhage or renal failure. Understanding the natural history of these lesions and understanding which lesions may be more prone to grow quickly ...
What is the current status of trial NCT00598455?
This trial is currently completed. The enrollment target is 450 participants. The study started on 2008-02. Estimated completion is 2013-09.
What conditions does trial NCT00598455 study?
This clinical trial studies the following conditions: Tuberous Sclerosis Complex.
Who is sponsoring clinical trial NCT00598455?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00598455 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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