NCT00004483

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
Last Updated

September 29, 2005

Status Verified

September 1, 2005

First QC Date

October 18, 1999

Last Update Submit

September 27, 2005

Conditions

Schwannoma, VestibularNeurofibromatosis 2Meningioma

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

House Ear Institute

Los Angeles, California, 90057-9927, United States

Location

Related Publications (7)

  • 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).

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1097/00129492-200403000-00012.

    PMID: 15021775BACKGROUND

  • 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. doi: 10.1097/01.mao.0000169048.15889.80.

    PMID: 16015177BACKGROUND

  • 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. doi: 10.1097/00129492-200409000-00027.

    PMID: 15354016BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Neuroma, AcousticNeurofibromatosis 2Meningioma

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesNeurofibromatosesNeurofibromaNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System Neoplasms

Study Officials

  • William H. Slattery, III

    House Ear Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

January 1, 2002

Last Updated

September 29, 2005

Record last verified: 2005-09

Locations

US(1)