Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced, Pediatric Cancer
Conditions
Brief summary
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.
Interventions
DEVICEAudiogram
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.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Pregnant or breast-feeding women can be included as no risk is identified * With Social security coverage * Signed written informed consent obtained NB: Patients included in another research project are not excluded from this one NB: patients wearing a Lyric hearing prosthesis or any other permanent hearing prosthesis or cochlear implant can be included in the study but will not perform audiological examinations because the audiogram can't be easily performed without hearing prosthesis. Nevertheless, these patients could participate to the study with self-administered questionnaires and could be included as cases (i.e. patients with hearing deficiency) in analyses.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of hearing loss by frequency and/or sound level | Baseline | 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 |
Countries
France
Contacts
Primary ContactBrice Fresneau, MD, PhD
Backup ContactPauline HOARAU, MSc
Outcome results
None listed