Status:
RECRUITING
Diagnostic of Various Ototoxicity Induced by Cancer Treatment
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Ototoxicity, Drug-Induced
Eligibility:
All Genders
18+ years
Brief 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) c...
Detailed Description
Ototoxicity refers to all the auditory and vestibular consequences of a mechanical, radiological and/or chemical aggressor, which can affect these functions via common or specific mechanisms. Quantif...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- \- 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, in particular otosclerosis, perilymphatic fistula, ruptured tympanic membrane, autoimmune hearing loss, acoustic neuroma.
- History of severe head trauma (Glasgow Coma Score \<= 8)
- Abnormal otoscopy or tympanometry In addition for group B
- Previous chemotherapy
- Previous ENT radiotherapy
- Ongoing ototoxic drug therapy (quinine, diuretics, aminoglycosides, aspirin, NSAIDs) or corticosteroid therapy
Key Trial Info
Start Date :
June 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 19 2027
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06490029
Start Date
June 19 2024
End Date
September 19 2027
Last Update
July 8 2024
Active Locations (1)
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1
HIA Bégin
Paris, France