Status:
NOT_YET_RECRUITING
Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Ototoxicity, Drug-Induced
Ototoxicity, Radiation-Induced
Eligibility:
All Genders
18-50 years
Phase:
NA
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-random...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06957132
Start Date
May 1 2025
End Date
April 1 2026
Last Update
May 4 2025
Active Locations (3)
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1
Hôpital Necker
Paris, France, 75015
2
Institut Curie
Paris, France, 75248
3
Gustave Roussy
Villejuif, France, 94805