cochlear organ toxicity, ototoxicity hearing loss
Conditions
Interventions
None listed
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
2 Years to 64 Years
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 will receive audiological examination as part of standard of care; 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, or planned to receive CNS-/ENT irradiation and/or CNS-/ENT surgery without audiological examination as part of standard of care; 3. Children aged 0 until 19 at time of diagnosis; 4. Study specific informed consent form (ICF) signed prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Critically ill, Intensive Care unit admission. 2. Presence of a solid tumor/ CNS tumor not planned to receive chemotherapy and/or planned to receive surgery or irradiation at other locations than the CNS-/ENT area, or were a watch-and-wait approach is applicable; 3.Identification of a recurrence/relapse tumor 4.Infaust prognosis at time of diagnosis/ palliative treatment only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters: 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. The definition of hearing loss will be: Pure tone audiometry: sensorineural hearing loss >40dB at >=4kHz, (corresponding to Munster grade >=2B) Frequency specific Auditory Brain Stem Response or Visual Reinforcement Audiometry : a sensorineural hearing loss >40 dB at >= 4 kHz. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: tinnitus and vertigo. Determinants: co-medication, cisplatin/ carboplatin dosage and levels, age, sex, CNS-/ENT irradiation, ENT surgery, neurosurgery. Liver and kidney function serum measurements are part of standard care during childhood cancer treatment. The results of these standard care measurements will be collected because platinol and co-medication are often excreted by liver and/or kidneys. | — |
Countries
Netherlands
Contacts
Public ContactM.M. Heuvel-Eibrink
Prinses Máxima Centrum voor Kinderoncologie
Outcome results
None listed