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NCT00598351 · ClinicalTrials.gov registry record
Natural History Study of Patients With Neurofibromatosis Type 2
A clinical trial of Neurofibromatosis, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- 269
- Enrollment target
- 1
- Study location
NCT00598351 is a study of Neurofibromatosis that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 269 participants, above the 76-participant average among 5 other Neurofibromatosis trials with a reported enrollment target (254% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00598351, a study of Neurofibromatosis, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- 269 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective With this prospective natural experiment trial on neurofibromatosis type 2 (NF2) study, we hope to understand the factors leading to tumor progression and neurological disease burden in NF2. Study Population A total of 269 participants, ages 8-75, with a clinical or genetic diagnosis of NF2 will participate in this study. Design Study participants will be evaluated with a thorough physical and neurologic examination upon enrollment. This initial outpatient evaluation will include magnetic resonance imaging with contrast of brain and spine and blood collection for research use. Participants with measurable hearing will have audiology assessment performed. Participants with untreated vestibular schwannomas will have vestibular assessment performed during the initial visit. Genetic studies performed outside will be acceptable as confirmation of NF2 in enrolled patients. If needed to confirm NF2 with genetic studies, or for research purpose, whole genome/whole exome sequencing may be performed on blood obtained from subjects enrolled in this study. All participants will be evaluated by a speech language pathologist. Subjects will be followed as outpatients for up to ten years, during which clinical, and radiologic evaluation will be performed annually. Auditory testing will be performed annually for participants with measurable hearing. Participants with initially untreated vestibular schwannomas will be followed annually with vestibular testing. Speech and swallowing reassessments will be repeated if worsening of speech or swallowing is reported. Blood will be collected at each visit for blood biomarker testing Outcome measures We hope to understand the biologic basis for speech and swallowing dysfunction in patients with NF2. We will study and report the strength of association of MRI findings, clinical assessments cranial nerve deficits and speech/swallowing dysfunction. We hope to identify imaging biomarkers of hearing loss in NF2. We will attempt
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2008-03-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00598351
The ClinicalTrials.gov registry entry for NCT00598351 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 269 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 76-participant average among 5 other Neurofibromatosis trials with a reported enrollment target (254% higher). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neurofibromatosis appearing as the primary indexed condition, and to 0 interventions.
NCT00598351 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00598351 about?
NCT00598351 is a clinical study titled "Natural History Study of Patients With Neurofibromatosis Type 2". Objective With this prospective natural experiment trial on neurofibromatosis type 2 (NF2) study, we hope to understand the factors leading to tumor progression and neurological disease burden in NF2. Study Population A total of 269 participants, ages 8-75, with a clinical or genetic diagnosis of...
What is the current status of trial NCT00598351?
This trial is currently recruiting. The enrollment target is 269 participants. The study started on 2008-03-21.
What conditions does trial NCT00598351 study?
This clinical trial studies the following conditions: Neurofibromatosis.
Who is sponsoring clinical trial NCT00598351?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00598351 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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