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Clinical Trials/NL-OMON54993
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Sponsor
Prinses Máxima Centrum

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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