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
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