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Clinical Trials/NCT03079544
NCT03079544
Completed
Not Applicable

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

Rong Tao2 sites in 1 country665 target enrollmentMarch 8, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extranodal NK-T-Cell Lymphoma, Nasal Type
Sponsor
Rong Tao
Enrollment
665
Locations
2
Primary Endpoint
overall survival
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2017
End Date
August 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rong Tao
Responsible Party
Sponsor Investigator
Principal Investigator

Rong Tao

Clinical Professor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • patients who are enrolled in any other clinical trials.
  • Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.

Outcomes

Primary Outcomes

overall survival

Time Frame: 2-year

The overall survial time of patients will be measured since the initiation of treatment to death of any reason.

Secondary Outcomes

  • 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)

Study Sites (2)

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