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

NCT06957132 | Not Yet Recruiting

• 2 other identifiers: 2024-A02705-422024/3979
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Study Arms (1)

Audiologic examination

OTHER

Add an audiogram in the patient consultation

Device: Audiogram

Interventions

Audiogram 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.

Also known as: iAudiogram medical device

Audiologic examination

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (3)

Hôpital Necker

Paris, 75015, France

Location

Institut Curie

Paris, 75248, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Ototoxicity; Neoplasms

Interventions

Audiometry

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Brice Fresneau, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brice Fresneau, MD, PhD

CONTACT

+33 (0)1 42 11 42 11; Brice.FRESNEAU@gustaveroussy.fr

Pauline HOARAU, MSc

CONTACT

+33 (0)1 42 11 42 11; pauline.hoarau@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)