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

NCT ID: NCT06957132

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-04-30

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.

Conditions

Ototoxicity, Drug-Induced; Ototoxicity, Radiation-Induced; Pediatric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Audiologic examination

Add an audiogram in the patient consultation

Group Type: OTHER

Audiogram

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

iAudiogram medical device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brice Fresneau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Hôpital Necker

Paris, , France

Institut Curie

Paris, , France

Gustave Roussy

Villejuif, , France

Countries

France

Central Contacts

Brice Fresneau, MD, PhD

Role: CONTACT

Brice.FRESNEAU@gustaveroussy.fr

+33 (0)1 42 11 42 11

Pauline HOARAU, MSc

Role: CONTACT

pauline.hoarau@gustaveroussy.fr

+33 (0)1 42 11 42 11

Facility Contacts

Nathalie LOUNDON, MD, PhD

Role: primary

nathalie.loundon@aphp.fr

François DOZ, MD, PhD

Role: primary

francois.doz@curie.fr

Brice Fresneau, MD, PhD

Role: primary

Brice.FRESNEAU@gustaveroussy.fr

+33 (0)1 42 11 42 11

Other Identifiers

2024/3979

Identifier Type: OTHER

Identifier Source: secondary_id

2024-A02705-42

Identifier Type: -

Identifier Source: org_study_id