跳至主要内容
临床试验/NCT05633719
NCT05633719尚未招募不适用

Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer

Seoul National University Hospital0 个研究点目标入组 300 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
Proportion of patients with ototoxic hearing loss

研究概览

简要总结

More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.

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
— 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ① Solid cancer patients under the age of 19 receiving Platinum chemotherapy
  • ② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy

排除标准

  • ① Those who have received chemotherapy or radiation in the past
  • Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

结局指标

主要结局

Proportion of patients with ototoxic hearing loss

时间窗: 1 year after the initiation of chemotherapy

Proportion of patients with ototoxic hearing loss in total patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moo Kyun, Park

Professor

Seoul National University Hospital

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