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Diagnostic of Various Ototoxicity Induced by Cancer Treatment

NCT06490029 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 540

Last updated 2024-07-08

No results posted yet for this study

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)

Conditions

  • Ototoxicity, Drug-Induced

Interventions

DIAGNOSTIC_TEST

Auditory, vestibular and electrophysiological investigations

otoacoustic emissions, electrocochleography, vocal audiometry in noise and high-frequency tonal audiometry, impedancemetry

DIAGNOSTIC_TEST

Biologic investigations; seric proteins

seric proteins

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Principal Investigators

  • François Régis FERRAND · IRBA, 1 place Valérie André, 91 223 Brétigny-sur-Orge cedex

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2025-03-19
Completion
2027-09-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490029 on ClinicalTrials.gov