Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 4:36 PM
Study NCT ID:
NCT06957132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2025-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISP-OTOTOX
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024/3979 | OTHER | CSET number (Gustave Roussy ID) | View |