NF2 Natural History Consortium

Meningioma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004483
• Other study ID #: 199/14226
• Secondary ID: HEI-NF2HEI-DAMD1
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 1999
• Last updated: September 27, 2005
• Start date: January 2002

Study information

• Verified date: September 2005
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Meningioma
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 2
• Neuroma, Acoustic
• Schwannoma, Vestibular

Locations

Country	Name	City	State
United States	House Ear Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
House Ear Institute

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Masuda, A., Fisher, LM, Oppenheimer, ML, Iqbal, Z., Slattery, WH., NF2 Study Group. (2004) Hearing Changes After Diagnosis in Neurofibromatosis 2 (NF2). Otolaryngology-Head and Neck Surgery. In press.

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).

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. — View Citation

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. — View Citation

Slattery, William H. III, Fisher, Laurel M. Considerations in the Development of the NF2 Natural History Consortium. Submitted to Otolaryngology-Head and Neck Surgery.

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.