Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood (RISP-OTOTOX)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brice Fresneau, MD, PhD
- Phone Number: +33 (0)1 42 11 42 11
- Email: Brice.FRESNEAU@gustaveroussy.fr
Study Contact Backup
- Name: Pauline HOARAU, MSc
- Phone Number: +33 (0)1 42 11 42 11
- Email: pauline.hoarau@gustaveroussy.fr
Study Locations
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-
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Paris, France, 75248
- Institut Curie
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Contact:
- François DOZ, MD, PhD
- Email: francois.doz@curie.fr
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Paris, France, 75015
- Hopital Necker
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Contact:
- Nathalie LOUNDON, MD, PhD
- Email: nathalie.loundon@aphp.fr
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Villejuif, France, 94805
- Gustave Roussy
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Contact:
- Brice Fresneau, MD, PhD
- Phone Number: +33 (0)1 42 11 42 11
- Email: Brice.FRESNEAU@gustaveroussy.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Audiologic examination
Add an audiogram in the patient consultation
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measurement of hearing loss by frequency and/or sound level
Time Frame: Baseline
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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:
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brice Fresneau, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A02705-42
- 2024/3979 (Other Identifier: CSET number (Gustave Roussy ID))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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