An interventional study of Audiogram in Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced and Pediatric Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Other
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.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's planned enrollment of 500 is above the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 245 studies on the registry; 66 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Add an audiogram in the patient consultation
Device: Audiogram
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.
Also known as: iAudiogram medical device
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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