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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 50 years at audiological investigations

Treated for brain tumor, solid cancer, lymphoma or leukemia in childhood, adolescence or at a young adult age (<25years)

With at least 5 years of cancer-free follow-up after childhood cancer

Patients included in the FCCSS ( https://fccss.fr ) deep cohort of 7670 5-year childhood cancer survivors treated before 2001, or patients who have planned visit in long-term follow-up clinics of Curie Institute and Gustave Roussy, whatever the diagnostic period

Disqualifiers

Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Patient with unavailable data concerning treatment modalities including cumulative doses of chemotherapy agents or radiation fields and dose

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Audiologic examinationOther 1 intervention

Trial outcomes

Primary outcomes

1

measurement of hearing loss by frequency and/or sound level

The patients explored with the automated tonal audiometry (iAudiogram medical device) with one of the following results as well as patients wearing a Lyric hearing prosthesis or any other permanent hearing prosthesis or cochlear implant will be considered as as having an audiological impairment: * Average hearing loss at 500Hz 1kHz 2kHz 4kHz 8kHz, ≥ 30dB * Hearing loss at least on 2 adjacent frequencies (among 500Hz 1kHz 2kHz 4kHz 8kHz) ≥ 30dB * Hearing loss at 8kHz ≥ 40dB (Brock1, according to Brock Grading system) * Asymmetrical hearing: interaural gap of ≥ 15 dB on two adjacent frequencies or interaural gap of ≥ 25 dB on one frequency * Abnormal result on high-frequency audiometry: hearing loss at least on 2 points on frequencies 11.2-16 kHz, ≥ 30 dB

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: