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

September 13, 2021 updated by: Rong Tao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

665

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100010
        • Lymphoma House086
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with the diagnosis of NK/TCL treated out of clinical trials are candidators for this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years
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.
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rong Tao

Investigators

  • Study Chair: Rong Tao, MD, Xinhua hospital, Shanghai Jiao Tong University of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHLSG-NK-1603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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