Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients

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.

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Key information

Conditions

Extranodal NK-T-Cell Lymphoma, Nasal Type Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Lymphoma House086, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Asparaginase or or Pegaspargase containing chemotherapy

Combination Product

Patients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase.

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

Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time frame: 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.
Progression free survival

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rong Tao

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Mar 14, 2017
Registry last updated: Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed