NCT05641441 Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma
| NCT ID | NCT05641441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Vestibular Schwannoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 258 participants |
| Start Date | 2023-01-24 |
| Primary Completion | 2030-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 258 participants in total. It began in 2023-01-24 with a primary completion date of 2030-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators aim to study the impact of stereotactic radiosurgery, for the treatment of vestibular Schwannoma, on the cochlear, vestibular, gustatory, and facial nerve functions and compare it with a conservatively treated group. The predictive value of radiological tumor characteristics on hearing preservation and vestibular function will be also evaluated. Additionally, the investigators will invite patients with vestibular Schwannoma to fill out questionnaires to assess their quality of life.
Eligibility Criteria
Inclusion Criteria: * Aged 18 years or above * 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: * Previous surgical or radiation therapy for VS (including SRS) * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05641441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vestibular Schwannoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05641441 currently recruiting?
Yes, NCT05641441 is actively recruiting participants. Contact the research team at pascal.senn@hcuge.ch for enrollment information.
Where is the NCT05641441 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT05641441 clinical trial?
NCT05641441 is sponsored by University Hospital, Geneva. The trial plans to enroll 258 participants.