Extranodal NK-T-Cell Lymphoma, Nasal TypeNCT03079544
Social Media-based Active Self-report on Incidence and Outcomes of Adverse Events in NK/TCL Patients
An observational study of Extranodal NK-T-Cell Lymphoma, Nasal Type, run by Rong Tao at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma, Nasal Type
- What is being tested?
- L-Asparaginase or or Pegaspargase containing chemotherapy
- How many people
- 665 participants
- Where
- 2 sitesChina
- Study dates
- 8 Mar 2017to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with the diagnosis of NK/TCL treated out of clinical trials are candidators for this study.
Who may be able to join
- 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.
Who cannot join
- patients who are enrolled in any other clinical trials.
- Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Lymphoma House086
Beijing, Beijing Municipality, 100010
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
About this study
Official 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
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.
Read the 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.
- Being tested
- L-Asparaginase or or Pegaspargase containing chemotherapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Asparaginase or or Pegaspargase containing chemotherapyCombination product
Patients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase.
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The overall survial time of patients will be measured since the initiation of treatment to death of any reason.
Measured: 2-year
Secondary outcomes (2)
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Chemotherapy-related and radiotherapy-related toxicities and adverse events will be collected and graded by NCI CTCAE v4.0 criteria.
Measured: Day 1 of each course of chemotherapy and radiotherapy then every 3 months for 2 years
Progression free survival
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.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start8 Mar 2017
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-Cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Rong Tao, MD, Study chair, Xinhua hospital, Shanghai Jiao Tong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079544
- Sponsor's protocol ID
- XHLSG-NK-1603
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03079544
- Acronym / sponsor ID
- XHLSG-NK-1603
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with the diagnosis of NK/TCL treated out of clinical trials are candidators for this study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- patients who are enrolled in any other clinical trials.
- Relapsed patients who were initially treated with non-L-asparaginas or non-pegaspargase based regimens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Asparaginase or or Pegaspargase containing chemotherapyPatients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase. | Combination product | – |
Primary outcome
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 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
Progression free survival
Time frame: 2-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Tao, MD study chair
Xinhua hospital, Shanghai Jiao Tong University of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extranodal NK-T-Cell Lymphoma, Nasal Type, run by Rong Tao at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.