Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
NCT ID: NCT05641441
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
258 participants
OBSERVATIONAL
2023-01-24
2030-11-15
Brief Summary
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Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
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Detailed Description
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The prospective study part aims to obtain more precise and predefined follow-up data from patients treated either with SRS or followed up conservatively from now on. Our institution's multidisciplinary skull base tumor board will be responsible for treatment decisions independently of the study. It will be a single-center observational cohort study investigating the respective impact of tumor morphology and SRS on the inner ear, the facial nerve function, and the quality of life of these patients. As data collection will be done prospectively, MRI acquisition parameters will be standardized, as well as quantification of hearing, vestibular, facial nerve function, and quality of life. Additionally, the investigators will analyze the characteristics of the tumors and several parameters of the irradiation protocol to develop predictive models for ototoxicity.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Stereotactic radiosurgery group
Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study.
Stereotactic radiosurgery
Stereotactic radiosurgery
Wait and scan group
Patients with unilateral Vestibular Schwannoma followed with an MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study.
No interventions assigned to this group
Interventions
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Stereotactic radiosurgery
Stereotactic radiosurgery
Eligibility Criteria
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Inclusion Criteria
* Patients with unilateral VS treated either with SRS or MRI-based observation strategy, as proposed by the institution's skull base tumor board independently of the study
* Patients willing to take part in the study and give their informed consent
Exclusion Criteria
* Patients diagnosed with neurofibromatosis type II
* Preexisting profound hearing loss, with a pure tone average (PTA) \>90 and word recognition score (WRS) \<10%, upon initial assessment
* Previous middle ear surgery of the affected ear
* Concurrent treatment with other experimental drugs
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Pascal Senn
Chairman of the Service of Otorhinolaryngology-Head and Neck Surgery, Department of clinical neurosciences, Geneva University Hospitals
Locations
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Service d'ORL et Chirurge cervico-faciale, Hopitaux Universitaires de Genève
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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2022-01257
Identifier Type: -
Identifier Source: org_study_id
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