Social Media-based Patient Education and Active Self-report on Incidence and Outcomes of Adverse Events in Natural Killer/T-cell Lymphoma (NK/TCL) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 665
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to collect data from patients by social media and self-report on the adverse events and outcomes happened with patients with extranodal natural killer/T-cell lymphoma, nasal type, who are treated outside of clinical trials in China.
详细描述
Extranodal natural killer/T-cell lymphoma, nasal type, is a rare subtype of non-Hodgkin lymphoma with relatively high incidence in China. L-asparaginase based chemotherapy are widely used with Chinese patients and has been reported to improve overall response and prolonged the long-term survival in some clinical trials with very limited patients. However, most patients were treated out of clinical trials in China. Therefore the real incidence of adverse events and treatment outcomes are largely unknown. This study is designed to evaluate the incidence of adverse events and treatment outcomes by social media-based (www.house086.com, www.wechat.com) self-report from patients who are treated out of clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
- •Treated with at least one cycle of L-asparaginas or Pegaspargase based chemotherapy.
- •Signed Informed consent.
排除标准
- •patients who are enrolled in any other clinical trials.
- •Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.
结局指标
主要结局
overall survival
时间窗: 2-year
The overall survial time of patients will be measured since the initiation of treatment to death of any reason.
次要结局
- Progression free survival(2-year)
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years)
研究者
Rong Tao
Clinical Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine