Actively Recruiting
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
Led by Direction Centrale du Service de Santé des Armées · Updated on 2024-07-08
540
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
• 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)
CONDITIONS
Official Title
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and over
- Registered with social security
- Signed consents
- Absence of presbycusis prior to cancer treatment (groups A and C)
- No known presbycusis (group B)
- Previous exposure to an ototoxic/neurotoxic agent (group A)
- Indication for initiation of ototoxic/neurotoxic therapy (group C)
You will not qualify if you...
- Subjects deprived of liberty
- Subjects unable to read or write the French language
- Pregnant and breast-feeding women
- Previous treatment for ototoxicity
- History of bilateral auditory pathology, including otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma
- History of severe head trauma (Glasgow Coma Score �3C= 8)
- Abnormal otoscopy or tympanometry
- For group B: previous chemotherapy
- For group B: previous ENT radiotherapy
- For group B: ongoing ototoxic drug therapy such as quinine, diuretics, aminoglycosides, aspirin, NSAIDs, or corticosteroid therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
HIA Bégin
Paris, France
Actively Recruiting
Research Team
F
François-Régis FERRAND
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
23
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