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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03079544
Enrollment
665
Registered
2017-03-14
Start date
2017-03-08
Completion date
2021-08-30
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal NK-T-Cell Lymphoma, Nasal Type

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.

Interventions

COMBINATION_PRODUCTL-Asparaginase or or Pegaspargase containing chemotherapy

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

Sponsors

Rong Tao
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
overall survival2-yearThe overall survial time of patients will be measured since the initiation of treatment to death of any reason.

Secondary

MeasureTime frameDescription
Treatment-Related Adverse Events as Assessed by CTCAE v4.0Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 yearsChemotherapy-related and radiotherapy-related toxicities and adverse events will be collected and graded by NCI CTCAE v4.0 criteria.
Progression free survival2-yearProgression 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026