NF2 Natural History Consortium

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Office of Rare Diseases (ORD). Recruitment status was Active, not recruiting

First Received on October 18, 1999. Last Updated on September 27, 2005 History of Changes

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:	Observational Model: Natural History Time Perspective: Longitudinal

Resource links provided by NLM:

Genetics Home Reference related topics: neurofibromatosis type 2 Help Me Understand Genetics

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.

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

Additional relevant MeSH terms:

Meningioma
Neurilemmoma
Neurofibromatosis 2
Neuroma, Acoustic
Neurofibromatoses
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nerve Sheath Neoplasms
Neuroma
Peripheral Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neurofibroma
Neoplastic Syndromes, Hereditary
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012