Ototoxicity, Drug-InducedRISP-OTOTOXNCT06957132
Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
A study testing Audiogram in people with Ototoxicity, Drug-Induced and Ototoxicity, Radiation-Induced, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced, Pediatric Cancer
- What is being tested?
- Audiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesFrance
- Study dates
- May 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hôpital Necker
Paris, 75015
Nathalie LOUNDON, MD, PhD, nathalie.loundon@aphp.fr
Institut Curie
Paris, 75248
François DOZ, MD, PhD, francois.doz@curie.fr
Gustave Roussy
Villejuif, 94805
Brice Fresneau, MD, PhD, +33 (0)1 42 11 42 11, Brice.FRESNEAU@gustaveroussy.fr
About this study
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.
- Being tested
- Audiogram
- Medical subject headings
- Ototoxicity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudiogramDevice
Also called iAudiogram medical 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.
| Study group | Role | What they receive |
|---|---|---|
| Audiologic examination | Other | Add an audiogram in the patient consultation Receives: Device: Audiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study startMay 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ototoxicity, Drug-InducedStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brice Fresneau, MD, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957132
- Sponsor's protocol ID
- 2024-A02705-42
- Other IDs
- 2024/3979
- Acronym
- RISP-OTOTOX
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
- ClinicalTrials.gov ID
- NCT06957132
- Acronym / sponsor ID
- RISP-OTOTOX / 2024-A02705-42
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Audiologic examination | Other | Device: AudiogramAdd an audiogram in the patient consultation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudiogramAlso: iAudiogram medical deviceEither 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. | Device | Audiologic examination |
Primary outcome
measurement of hearing loss by frequency and/or sound level
Time frame: Baseline
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brice Fresneau, MD, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiogram in people with Ototoxicity, Drug-Induced and Ototoxicity, Radiation-Induced, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brice Fresneau, MD, PhD (+33 (0)1 42 11 42 11, Brice.FRESNEAU@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of hearing loss by frequency and/or sound level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.