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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00598351 |
This study will examine over the long-term the progress of patients with neurofibromatosis Type 2 (NF2), a condition associated with tumors of the nerves, brain and spinal cord. It will study patients' tumors to learn how fast they can grow and if certain factors might affect their growth. It will also examine the effects of the tumors on patients' abilities to carry out activities of daily living.
People between 8 and 75 years of age with NF2 may be eligible for this study. Participants undergo the following procedures:
Initial evaluation, including hearing, eye and balance testing, gait (walk) testing, magnetic resonance imaging (MRI) scans of the brain and spine, blood tests, and physical and neurological examinations.
MRI scans of the brain and spine every 6 months to follow the size and number of tumors.
Physical and neurological examinations and blood tests every 6 months.
Auditory tests every 12 months. These tests evaluate middle and inner ear function and the patient's ability to hear tones at different frequencies and to hear words at different volumes. The subject responds to tones and words that are delivered through earphones.
Eye examination every 1 to 2 years.
Gait testing every 12 months if a spinal cord tumor causes problems with sensation or muscle control in the arms and legs - Subjects' joints are measured while they walk across a room several times as scientific cameras record their movements.
Vestibular testing if the patient experiences changes in balance or undergoes treatment for vestibular schwannoma (a tumor that develops on the hearing and balance nerves). These tests check the function of various components of the balance system (eyes, inner ear, or leg and body sensation and muscles). They include:
Condition |
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Spinal Cord Disease Intracranial Central Nervous System Disorder Neurologic Disorders Brain Neoplasms |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | A Prospective Natural History Study of Patients With Neurofibromatosis Type 2 (NF2) |
Estimated Enrollment: | 250 |
Study Start Date: | January 2008 |
Objective
The objective of this prospective natural history study on neurofibromatosis type 2 (NF2) is to gain clinical and molecular insight into the effects of this tumor suppressor syndrome on tumor development and progression and to identify factors linked to symptom evolution.
Study Population
Two hundred fifty patients, 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 ophthalmologic examination, auditory and vestibular testing, magnetic resonance imaging with contrast of the craniospinal axis, NF2 gene testing and serum biomarker testing. In patients with spinal cord tumors, gait testing will also be performed.
Subjects will be followed as outpatients for five years, during which clinical, radiologic and serum biomarker evaluation will be performed every six months. Auditory testing will be performed annually. Patients with spinal cord tumors will be followed annually with gait testing. Ophthalmologic evaluation will be performed every one to two years, depending on the severity of ocular lesions. Vestibular testing will be repeated if balance dysfunction develops. If clinical symptoms attributable to any NF2-associated lesion are progressive in nature or warrant treatment intervention, testing may be repeated more frequently.
Outcome measures
Based on data derived from this study, we hope to identify factors that predict tumor development, forecast tumor growth and that underlie symptom formation. These findings should permit the safer treatment of the subset of tumors that will cause symptoms and avoid the unnecessary treatment of lesions that will remain stable (not requiring treatment) in these patients. Moreover, this prospective natural history study should be useful in identifying the stochastic factors that underlie the biology of these tumors.
Ages Eligible for Study: | 8 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080044, 08-N-0044 |
Study First Received: | January 10, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00598351 |
Health Authority: | United States: Federal Government |
Meningioma Ependymoma Schwannoma Acoustic Neuroma |
Vestibular Schwannoma Neurofibromatosis Type 2 NF2 |
Vestibulocochlear Nerve Diseases Otorhinolaryngologic Neoplasms Spinal Cord Diseases Neuroma, Acoustic Retrocochlear Diseases Central Nervous System Neoplasms Acoustic neuroma Brain Diseases Neurodegenerative Diseases Ear Diseases Ependymoma Neurofibromatosis 1 Neurofibromatosis 2 Heredodegenerative Disorders, Nervous System Neurofibroma |
Neuromuscular Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Meningioma Nervous System Neoplasms Neurocutaneous Syndromes Otorhinolaryngologic Diseases Central Nervous System Diseases Neurilemmoma Neurofibromatosis type 1 Neurofibromatosis type 2 Neuroendocrine Tumors Brain Neoplasms Neuroectodermal Tumors Neoplastic Syndromes, Hereditary |
Neoplasms Neoplasms by Histologic Type Pathologic Processes Neoplasms by Site Disease |
Neoplasms, Nerve Tissue Nervous System Diseases Cranial Nerve Neoplasms Cranial Nerve Diseases |