Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT06957132
Status
Not Yet Recruiting

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Conditions

  • Ototoxicity, Drug-Induced
  • Ototoxicity, Radiation-Induced
  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Audiogram — DEVICE
    Either the patient can be proposed to perform the audiogram during their long-term consultation, or they will be contacted by the physician to come especially for the project and realize the audiogram. iAudiogram is an Artificial Intelligence (AI) - automated audiometry platform (https://iaudiogram.com/), certified CE (European conformity). This examination will be performed once within the study.

Study Details

This study is aimed at people treated for cancer before the age of 25, who have been followed for at least 5 years, and who are now aged between 18 and 50. It is a prospective, multicenter, non-randomized study. The main aim of the project is to identify hearing impaired patients using the iAudiogram medical device, and to analyze the risk factors associated with the risk of hearing impairment. Around 500 patients will take part in this study in France. Participation in this research project will consist in carrying out a hearing test (audiogram with tonal audiometry) with the iAudigram medical device (at Gustave Roussy, Curie or Necker Hospital) and completing self-questionnaires focusing on ototoxicity and its consequences.

Key Dates

First listed
May 4, 2025
Start date
May 31, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Audiologic examination
    Add an audiogram in the patient consultation

Primary Outcome Measure

measurement of hearing loss by frequency and/or sound level [ Time Frame: Baseline ]

Central Contacts

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