NL-OMON54993
Recruiting
Not Applicable
A prospective study on prevalence and determinants of ototoxicity during treatment of childhood cancer - The SOUND study
Prinses Máxima Centrum0 sites600 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cochlear organ toxicity
- Sponsor
- Prinses Máxima Centrum
- Enrollment
- 600
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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