跳至主要内容
临床试验/NL-OMON54993
NL-OMON54993招募中不适用

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

Prinses Máxima Centrum0 个研究点目标入组 600 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
0 至 17(—)

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Prinses Máxima Centrum

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