A prospective study on prevalence and determinants of ototoxicity during treatment of childhood cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 600

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters:<br /><br>The primary objective of this study is to determine the prevalence of children<br /><br>with hearing loss at time of discontinuation of cancer therapy in a prospective<br /><br>full cohort of 600 children with solid and CNS tumors.<br /><br><br /><br>The definition of hearing loss will be:<br /><br>Pure tone audiometry: sensorineural hearing loss >40dB at >=4kHz, (corresponding<br /><br>to Munster grade >=2B)<br /><br>Frequency specific Auditory Brain Stem Response or Visual Reinforcement<br /><br>Audiometry : a sensorineural hearing loss >40 dB at >= 4 kHz.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes: tinnitus and vertigo.<br /><br>Determinants: co-medication, cisplatin/ carboplatin dosage and levels, age,<br /><br>sex, CNS-/ENT irradiation, ENT surgery, neurosurgery.<br /><br><br /><br>Liver and kidney function serum measurements are part of standard care during<br /><br>childhood cancer treatment. The results of these standard care measurements<br /><br>will be collected because platinol and co-medication are often excreted by<br /><br>liver and/or kidneys.<br /><br><br /><br></p><br>