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ClinicalTrials.gov ID

NCT06957132

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

500Estimated

Last Update Posted

May 4, 2025Actual

Start Date

May 2025Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

Official Title

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

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.

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

• Audiogram

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gustave Roussy, Cancer Campus, Grand ParisOTHER

francois.doz@curie.fr

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