NCT02644993Unknown不适用
Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Quality of Life Questionnaire
研究概览
简要总结
The study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 18 years of age
- •patient who is planned to receive proton therapy at Samsung Medical Center
- •Informed consent
排除标准
- •Refuse to participate this cohort study
研究组 & 干预措施
Proton beam therapy
Experimental
干预措施: Proton therapy (Radiation)
结局指标
主要结局
Quality of Life Questionnaire
时间窗: within 2 weeks before proton beam therapy
次要结局
- Adverse event(10 years after proton beam therapy)
- Quality of Life Questionnaire(10 years after proton beam therapy)
- Quality of Life Questionnaire baseline(within 1 week before proton beam therapy completion)
- Quality of Life Questionnaire(5 years after proton beam therapy)
- Quality of Life Questionnaire(3-6 months after proton beam therapy)
- Quality of Life Questionnaire(1 year after proton beam therapy)
- Quality of Life Questionnaire(3 years after proton beam therapy)
- Adverse event(3-6 months after proton beam therapy)
- Adverse event(1 year after proton beam therapy)
- Adverse event(3 years after proton beam therapy)
- Adverse event(5 years after proton beam therapy)
研究者
Do Hoon Lim
Professor
Samsung Medical Center
研究点 (1)
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