Prospective Study on Quality of Life in Patients With Intracranial Germ Cell Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)
研究概览
简要总结
The primary purpose of this study is to characterize the quality of life in patients with intracranial germ cell tumors. Those findings can contribute towards a better understanding of the impact of the current treatment strategy on survivors.
详细描述
The characteristics of the quality of life in patients with intracranial germ cell tumors are far from understood. The main reason is the rare occurrence of the disease. As a result, most findings came from retrospective studies in which only dozens of patients participated. Generally, patients with intracranial germ cell tumors have a good prognosis, especially those with germinoma.
Over 90% of patients with germinoma will survival after ten years of follow-up. Thus, the quality of life in long-term survivors is of concern. The investigators designed this prospective study to address this issue to understand better the characteristics of the quality of life in patients with intracranial germ cell tumors and provide information for optimizing the current treatment strategy.
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 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 years ≤ age ≤ 21 years
- •Newly diagnosed primary intracranial germ cell tumors
- •Written informed consent
排除标准
- •Relapsed disease
- •Poor compliance
结局指标
主要结局
Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)
时间窗: Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.
The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL. (age ≤18 years)
次要结局
- Change of score of the QoL questionnaire (Short form-36)(Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment.)
研究者
Tao Jiang
President
Beijing Tiantan Hospital