Central nervous system tumor or solid tumor
Conditions
Interventions
None listed
Sponsors
Trial Data Center Princes Màxima Center for pediatric oncology
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine the prevalence of children with hearing loss at time of discontinuation of cancer therapy in a prospective full cohort of 600 children with solid and CNS tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: - To study the feasibility of standard of care audiological (hearing loss, tinnitus and vertigo) testing of all patients with solid and CNS tumors treated with platinum, CNS- /ENT irradiation, CNS-/ENT surgery, before and after childhood cancer therapy by using standardized diagnostic tests, timing and frequency of audiological evaluations in this population (stratum 1). - To gain insight into the relative contribution of cancer treatment components, clinical characteristics and supportive care co-treatment (aminoglycosides, loop diuretics, and vancomycin) on hearing loss in children with solid and CNS tumors that doreceive platinum derivates and/or CNS-/ENT irradiation, and/or CNS/ENT surgery, by performing standard audiological testing at the end of treatment (stratum 1). - To gain insight into the relative contribution of supportive care medication (aminoglycosides, loop diuretics, and vancomycin) on hearing loss in children with solid and CNS tumors that do not receive platinum derivates and/or CNS-/ENTirradiation and/or CNS/ENT surgery, by performing audiological testing at the end of treatment (stratum 2). - To determine the effect of platinum dose and levels, irradiation dose, co-medication dose and levels on ototoxicity at the end of treatment (stratum 1). - To gain insight in the frequency and characteristics of patients with abnormalities in audiological testing (hearing loss, tinnitus and vertigo) occurring during childhood solid tumor and CNS cancer treatment (stratum 1 and 2). - To create a registry with outcomes of audiological evaluations and potential determinants for ototoxicity during childhood cancer therapy (stratum 1 and 2), which can be used for further research on innovation and enhancing of audiological testing and genetic susceptibility studies. | — |
Contacts
Public ContactRobin Diepstraten
Princess Máxima Center
Outcome results
None listed