Clinical trial NCT06957132: Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
Official title: Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ototoxicity, Drug-Induced
Ototoxicity, Radiation-Induced
Pediatric Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: measurement of hearing loss by frequency and/or sound level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Institut Curie
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Brice Fresneau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: