NF2 Natural History Consortium - Full Text View

Sponsor:	House Ear Institute
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004483

Purpose

OBJECTIVES:

I. Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.

Condition
Schwannoma, Vestibular Neurofibromatosis 2 Meningioma

Study Type:	Observational
Study Design:	Natural History, Longitudinal

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 1 neurofibromatosis type 2

MedlinePlus related topics: Neurofibromatosis

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	100
Study Start Date:	January 2002

Detailed Description:

PROTOCOL OUTLINE: Data on the clinical course and growth rate of NF2-related tumors in patients with neurofibromatosis 2. Patients are evaluated each year on a cranial and a spinal MRI, eye tests, hearing tests, quality of life, neurological tests, and physical functioning.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosed with neurofibromatosis 2 on or after 01/01/93
Must meet one of the following conditions:

Bilateral vestibular schwannoma OR Family history of neurofibromatosis 2 (first degree family relative) AND Unilateral vestibular schwannoma at under 30 years OR Any 2 of the following: Meningioma Glioma Schwannoma Juvenile posterior subcapsular lenticular opacity/juvenile cortical cataract

No plans to treat vestibular schwannoma in next 12 months

--Prior/Concurrent Therapy--

Not specified

--Patient Characteristics--

Age: 5 and over

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004483

Locations

United States, California
House Ear Institute
Los Angeles, California, United States, 90057-9927

Sponsors and Collaborators

House Ear Institute

Investigators

Study Chair:

William H. Slattery, III

House Ear Institute

More Information

Publications:

Masuda, Ann. Slattery, William H. III, Fisher, Laurel M., Oppenheimer, Mark. Audiological Characteristics of Initial Presentation of NF2 Patients: Preliminary Results. Abstract submitted to: Combined Otolaryngological Spring Meetings (COSM).

Fisher, Laurel M., Slattery, WIlliam H. III, Yoon, Gloria. MRI Test-Retest Study of NF2 Patients. Abstract Submitted to: Combined Otolaryngological Spring Meetings (COSM).

Masuda A, Fisher LM, Oppenheimer ML, Iqbal Z, Slattery WH; Natural History Consortium. Hearing changes after diagnosis in neurofibromatosis type 2. Otol Neurotol. 2004 Mar;25(2):150-4.

Slattery WH, Lev MH, Fisher LM, Connell SS, Iqbal Z, Go JL; NF2 Natural History Consortium. MRI evaluation of neurofibromatosis 2 patients: a standardized approach for accuracy in interpretation. Otol Neurotol. 2005 Jul;26(4):733-40.

Slattery WH 3rd, Fisher LM, Iqbal Z, Oppenhiemer M. Vestibular schwannoma growth rates in neurofibromatosis type 2 natural history consortium subjects. Otol Neurotol. 2004 Sep;25(5):811-7.

Zacharia, T., Lev, M., Iqbal, Z.T., Fisher ,L.M. , Gupta, MS, Slattery, WH. (2003) Intramedullary Spinal Tumors In NF II: Incidence And Imaging Characteristics American Radiology Society, 2003.

Study ID Numbers:	199/14226, HEI-NF2, HEI-DAMD17-01-1-0710
Study First Received:	October 18, 1999
Last Updated:	September 27, 2005
ClinicalTrials.gov Identifier:	NCT00004483 History of Changes
Health Authority:	Unspecified

Additional relevant MeSH terms:

Vestibulocochlear Nerve Diseases
Meningeal Neoplasms
Otorhinolaryngologic Neoplasms
Neuroma, Acoustic
Retrocochlear Diseases
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Central Nervous System Neoplasms
Neurodegenerative Diseases
Ear Diseases
Neurofibromatosis 1
Neurofibromatosis 2
Heredodegenerative Disorders, Nervous System
Neoplasms by Site
Neuromuscular Diseases

Neurofibroma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Vascular Tissue
Meningioma
Nervous System Neoplasms
Neurocutaneous Syndromes
Otorhinolaryngologic Diseases
Neoplasms by Histologic Type
Nervous System Diseases
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on November 22, 2009