Clinical Trial

Diagnostic of Various Ototoxicity Induced by Cancer Treatment

Study acronym: BIO-OTOTOX
Recruiting
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Record status
This record was last updated July 8, 2024 (before its estimated March 19, 2025 completion). Its status may not reflect the trial's current state.
Summary
• Visit the clinic once every 2 weeks for checkups and tests The goal of this clinical trial is to learn if systematic hearing tests (eg fonctional assesment, electrophysiology and seric biomarkers) can diagnose hidden hearing loss or vestibular troubles in a population of patients treated for cancer; population study will include different population in terms of sex/gender, age, medical condition (cancer patients treated with surgery alone and/or radiotherapy and/or chemotherapy, and healthy volunteers). The main question it aims to answer is: • To assess the ototoxicity of anticancer drugs using a combination of auditory functional tests (including speech audiometry in noise), vestibular test , plasmatic samples and electrophysiological measures. Participants will be studied: Either only after exposition (single visit) Or before, during and after the exposition to potential otototoxic agents with a 4 times Visit the clinic checkups and tests (one before, two while ongoing potential ototoxic agents and 1 post exposition) Participants will complete questionnaires, undergo audiometric and electrophysiological tests, and their routine biomedical data will be studied, without any modification of the routine care (planned cancer treatment)
Trial Details
NCT Number NCT06490029
Lead Sponsor Direction Centrale du Service de Santé des Armées
Conditions Ototoxicity, Drug-Induced
Enrollment 540 participants
Start Date 2024-06-19
Primary Completion 2025-03-19 (estimated)
Study Completion 2027-09-19 (estimated)
Updated on ClinicalTrials.gov 2024-07-08