NCT03866460已完成不适用
Determination of Hearing Status in Children Receiving Intra-Arterial Carboplatin for Intraocular Retinoblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Estimate the incidence of hearing loss
研究概览
简要总结
The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent indicating awareness of the investigational nature of the protocol.
- •Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy.
- •Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants
排除标准
- •Children with known and documented preexisting hearing loss.
结局指标
主要结局
Estimate the incidence of hearing loss
时间窗: 1 year
will be defined as a \>10 db loss from baseline in any frequency, based on the lower threshold of the American Speech and Hearing Associations (ASHA) hearing change criteria. For children unable to cooperate for an audiogram, the DPOAE will be the primary measurement.
次要结局
未报告次要终点
研究者
研究点 (1)
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