An observational study in Vestibular Schwannoma and Ototoxicity, sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by University Hospital, Geneva · Observational
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.
The study will have a retrospective part and a prospective part. The retrospective study will be based on a series of consecutive patients with vestibular Schwannoma (VS) treated either with stereotactic radiosurgery (SRS) or followed up radiologically between 2014 and 2021 in our institution. The following data will be retrieved from the hospital archiving system and will be subsequently analyzed: demographics, patient characteristics, details regarding SRS planning, clinical baseline and follow-up data, hearing, vestibular and taste function assessment initially and during follow-up, presence of additional symptoms (tinnitus, hemifacial spasm, trigeminal neuralgia), radiosurgery parameters and MRI characteristics of tumors. The following parameters will be retrospectively measured on MRI images by an experienced radiologist in each VS: tumor volume, ratio of brain stem compression, tumor shape and distance to the fundus of the internal auditory canal, length of the tumor in the internal auditory canal, and signal intensity in the cochlea and vestibule. The MRI textural features extracted from whole tumor segmentation of VSs will be calculated and analyzed with MatLab®. They include shape features, first order and second order textural features.
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.
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
This study's planned enrollment of 258 is above the median of 61 across 26 observational studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be conducted at the Geneva University Hospitals (tertiary care facility) in Switzerland. For the retrospective part of our research project, the investigators aim to analyze non-genetic health-related personal data in a coded form from approximately 150 patients treated between 2014 and 2021.
Regarding the prospective study part, patient recruitment will be done through the multidisciplinary skull base tumor board, where cases are discussed in detail, treatment decisions are made consensually based on the contribution of different specialists and in agreement with the current international recommendations. Patients eligible for study inclusion will be contacted to obtain informed consent. The investigators aim to include 108 participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with unilateral Vestibular Schwannoma treated with stereotactic radiosurgery, as proposed by the institution's skull base tumor board independently of the study.
Radiation: Stereotactic radiosurgery
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.
Stereotactic radiosurgery
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Time frame: 1-year
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Time frame: 1-year
Change of Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 500 Hz, 1000 Hz, 2000 Hz and 3000 Hz.
Time frame: 3 and 5-year
Change of High-frequency Pure Tone Average from baseline
Hearing status as measured by audiometric tonal testing and calculated from the average of 3000 Hz, 4000 Hz and 6000 Hz.
Time frame: 1, 3 and 5-year
Change of Word recognition score from baseline
Hearing status as measured by audiometric vocal testing and calculated as the percentage of correctly identified monosyllabic words presented at the speech recognition threshold + 40 decibel hearing level
Time frame: 3 and 5-year
Change of video-oculography from the baseline
Video-oculography assessment to detect a pathologic nystagmus or a pathologic smooth pursuit
Time frame: 1, 3 and 5-year
Change of caloric ipsilateral testing (degree of asymmetry) from baseline
Caloric testing to assess the vestibulo-ocular reflex in the low-frequency range.
Time frame: 1, 3 and 5-year
Change of the cervical Vestibular Evoked Myogenic Potential (cVEMP) from baseline
Assessment of a present or absent reflex which reflects the function of saccule
Time frame: 1, 3 and 5-year
Change of the ocular Vestibular Evoked Myogenic Potential (oVEMP) from baseline
Assessment of a present or absent reflex which reflects the function of utricle
Time frame: 1, 3 and 5-year
Change of the Video Head Impulse Test (VHIT) from baseline
Assessment of the VHIT to detect dysfunction of the vestibulo-ocular reflex in the high-frequency range.
Time frame: 1, 3 and 5-year
Change of facial nerve function from baseline
House-Brackmann scale score ranges from 1 (best) to 6 (worst)
Time frame: 1, 3 and 5-year
Change of taste function from baseline
"Taste strips" test score ranges from 0 (worst) to 16 (best) on each side of the tongue
Time frame: 6 and 12-month
Change of 36-Item Short Form Health Survey (SF-36) score from baseline
SF-36 score ranges from 0 (worst) to 100 (best)
Time frame: 1, 3 and 5-year
Change of Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score from baseline
Penn Acoustic Neuroma Quality-of-Life (PANQOL) scale score ranges from 0 (worst) to 100 (best)
Time frame: 1, 3 and 5-year
Change of Tinnitus Handicap Inventory (THI) score from baseline
Tinnitus Handicap Inventory (THI) score ranges from 0 (best) to 100 (worst)
Time frame: 1, 3 and 5-year
Plan to share: Undecided
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