Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients
- Conditions
- Extranodal NK-T-Cell Lymphoma, Nasal Type
- Registration Number
- NCT03079544
- Lead Sponsor
- Rong Tao
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 665
- 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.
- patients who are enrolled in any other clinical trials.
- Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival 2-year The overall survial time of patients will be measured since the initiation of treatment to death of any reason.
- Secondary Outcome Measures
Name Time Method Progression free survival 2-year Progression free survival time is defined as the time from the initiation of treatment to the date on which disease "progresses" or the date on which the patient dies, from any cause.
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 Chemotherapy-related and radiotherapy-related toxicities and adverse events will be collected and graded by NCI CTCAE v4.0 criteria.
Trial Locations
- Locations (2)
Xinhua Hospital
🇨🇳Shanghai, Shanghai, China
Lymphoma House086
🇨🇳Beijing, Beijing, China