Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood (RISP-OTOTOX)

Gustave Roussy

Status

Not yet enrolling

Conditions

Ototoxicity, Radiation-Induced

Ototoxicity, Drug-Induced

Pediatric Cancer

Treatments

Device: Audiogram

Study type

Interventional

Funder types

Other

Identifiers

NCT06957132

2024/3979 (Other Identifier)

2024-A02705-42

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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