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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08558 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22-009510 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC250709 | Other Identifier | Mayo Clinic |
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This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo vestibular function testing with video head impulse testing, sinusoidal harmonic acceleration testing, and pure tone audiometry and complete questionnaires throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in clinically significant vestibulopathy - vestibular function | Assessed using standard vestibular function testing. Results will be aggregated to determine overall vestibular function. Results from baseline (prior to initiating immunotherapy) will be compared to results at 3, 6, and 12 months. | Baseline, 3 months, 6 months, 12 months |
| Change in clinically significant vestibulopathy - hearing level | Assessed using Pure Tone Audiometry, a standard hearing test. Any change from baseline (prior to initiating immunotherapy) to 12 months will be reported. | Baseline,12 months |
| Oscillopsia Severity Questionnaire (OSQ) | The OSQ consists of 9 questions to assess visual environment sensation (episodes of oscillopsia). Questions are answered on a 5-point scale: always, often, sometimes, seldom, never. The OSQ is scored by calculating a mean item score, which results in a total score ranging from 1 to 5. A score of 3 or higher indicates moderate to extreme oscillopsia severity. | Baseline, 3 months, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who will be initiating single agent immunotherapy with pembrolizumab, cemiplimab, nivolumab, atezolizumab, or dual therapy with ipilimumab/nivolumab or nivolumab/relatlimab.
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| Name | Affiliation | Role |
|---|---|---|
| Carrlene B. Donald, PA-C, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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