A prospective Study on prevalence and determinants of Ototoxicity dUring treatmeNt of childhooD cancer
- Conditions
- Central nervous system tumor or solid tumor
- Registration Number
- NL-OMON23866
- Lead Sponsor
- Trial Data Center Princes Màxima Center for pediatric oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
In order to be eligible to participate in stratum 1, a subject must meet all of the following criteria:
1. Diagnosed with a CNS tumor or solid tumor in the Princess Máxima Center and
2. Planned to receive treatment with cisplatin and/or carboplatin and/ or oxaliplatin and/or CNS-/ENT irradiation
and/or CNS-/ENT surgery and
3. Children aged 0 until 19 years at time of diagnosis.
4. Biobank/ over de drempel PIF, Informed Consent Form (ICF) signed for collection of standard of care data.
In order to be eligible to participate in stratum 2, a subject must meet all of the following criteria:
1. Diagnosed with a CNS tumor or solid tumor in the Princess Máxima Center and
2. Not planned to receive treatment with cisplatin and/or carboplatin and/or oxaliplatin and/or CNS-/ENT
irradiation and/or CNS-/ENT surgery and
3. Children aged 0 until 19 at time of diagnosis and
4. Study specific informed consent form (ICF) signed prior to participation in the study.
Critically ill, Intensive Care unit admission because of which audiological evaluation is not possible before
start chemotherapy and/or CNS-/ENTradiotherapy and/or CNS-/ENT surgery
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the prevalence of children with hearing<br>loss at time of discontinuation of cancer therapy in a prospective full cohort of 600 children<br>with solid and CNS tumors
- Secondary Outcome Measures
Name Time Method