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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/3979 | Other Identifier | CSET number (Gustave Roussy ID) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiologic examination | Other | Add an audiogram in the patient consultation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Baseline |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Brice Fresneau, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker | Paris | 75015 | France |
|
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| Institut Curie | Paris | 75248 | France |
|
| Gustave Roussy | Villejuif | 94805 | France |
|
| ID | Term |
|---|---|
| D000081015 | Ototoxicity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D001299 | Audiometry |
| ID | Term |
|---|---|
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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