Schwannoma, VestibularNCT00004483
NF2 Natural History Consortium
An observational study of Schwannoma, Vestibular and Neurofibromatosis 2, run by House Ear Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Schwannoma, Vestibular, Neurofibromatosis 2, Meningioma
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
House Ear Institute
Los Angeles, California, 90057-9927
About this study
OBJECTIVES:
- Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.
Read the 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.
- Conditions
- Schwannoma, Vestibular, Neurofibromatosis 2, Meningioma
- Medical subject headings
- Neuroma, Acoustic, Neurofibromatosis 2, Meningioma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Schwannoma, VestibularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- House Ear Institute
- Sponsor type
- University, hospital or other
- Investigators
- William H. Slattery, III, Study chair, House Ear Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004483
- Sponsor's protocol ID
- 199/14226
- Other IDs
- HEI-NF2, HEI-DAMD17-01-1-0710
- Status last verified
- Sep 2005
- First submitted
- 18 Oct 1999
- Last updated
- 29 Sep 2005
- Results posted
- No
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).
Slattery, William H. III, Fisher, Laurel M. Considerations in the Development of the NF2 Natural History Consortium. Submitted to Otolaryngology-Head and Neck Surgery.
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.
PubMed 15021775Slattery 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.
PubMed 16015177Slattery, W.H., Fisher, L.M., Iqbal, Z., & Oppenheimer, M., Lev, MH., NF2 Study Group. (2004). Vestibular Schwannoma Growth Rates in NF2 Natural History Consortium Patients. Otolaryngology-Head and Neck Surgery. In Press.
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.
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 at a glance
From the registry record, last updated by the sponsor on 29 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NF2 Natural History Consortium
- ClinicalTrials.gov ID
- NCT00004483
- Acronym / sponsor ID
- 199/14226
- Conditions
- Schwannoma, Vestibular, Neurofibromatosis 2, Meningioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- House Ear InstituteUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Define the growth rates and clinical course of NF2-related tumors in patients with neurofibromatosis type 2. Associate growth rate with physical function.
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.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2005.
- BackgroundMasuda, 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).
- BackgroundFisher, Laurel M., Slattery, WIlliam H. III, Yoon, Gloria. MRI Test-Retest Study of NF2 Patients. Abstract Submitted to: Combined Otolaryngological Spring Meetings (COSM).
- BackgroundSlattery, William H. III, Fisher, Laurel M. Considerations in the Development of the NF2 Natural History Consortium. Submitted to Otolaryngology-Head and Neck Surgery.
- Background: PubMed 15021775Masuda 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.
- Background: PubMed 16015177Slattery 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.
- BackgroundSlattery, W.H., Fisher, L.M., Iqbal, Z., & Oppenheimer, M., Lev, MH., NF2 Study Group. (2004). Vestibular Schwannoma Growth Rates in NF2 Natural History Consortium Patients. Otolaryngology-Head and Neck Surgery. In Press.
- BackgroundMasuda, 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.
- BackgroundZacharia, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H. Slattery, III study chair
House Ear Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schwannoma, Vestibular and Neurofibromatosis 2, run by House Ear Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004483, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2005.