Extranodal NK/T-cell LymphomaNCT04554511
Prognostic Nomogram of Extranodal NK/T-cell Lymphoma
An observational study of Extranodal NK/T-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate prognostic factors for overall survival and explore risk progression-free survival in ENKTL, and establish a prognostic predictive nomogram for ENKTL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2020to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020; 2. Patients older than 18 years.
Who may be able to join
- Patients newly diagnosed with ENKTL
- Patients diagnosed between January 1, 2000 and August 31, 2020
- Patients older than 18 years
Who cannot join
- Patients who did not have complete clinical information or immunohistochemistry, or who were lost follow-up immediately after treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
hua wang, MD., 0086-02087342462, wanghua@sysucc.org.cn
About this study
Official title: Prognostic Nomogram of Extranodal NK/T-cell Lymphoma: A Multi-center Retrospective Study
This study aims to evaluate prognostic factors for overall survival and explore risk progression-free survival in ENKTL, and establish a prognostic predictive nomogram for ENKTL patients.
Read the detailed description
This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL between January 1, 2000 and August 31, 2020; (2) Patients older than 18 years. The pathology of initial diagnosis was reviewed by designated pathologists.
- Conditions
- Extranodal NK/T-cell Lymphoma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020. | |
| Validation Cohort | Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time between the date of diagnosis and any kinds of death
Measured: 5 year
Secondary outcomes (1)
Progression-free survival
Time between the date of diagnosis and any kinds of death or relapse/progression
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start28 Aug 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Wang, Sun Yat-sen University
- Investigators
- Hua Wang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554511
- Sponsor's protocol ID
- ENKTL-2020
- Status last verified
- Jun 2023
- First submitted
- 12 Sep 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Nomogram of Extranodal NK/T-cell Lymphoma: A Multi-center Retrospective Study
- ClinicalTrials.gov ID
- NCT04554511
- Acronym / sponsor ID
- ENKTL-2020
- Conditions
- Extranodal NK/T-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 18 Sep 2020 (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.
This study aims to evaluate prognostic factors for overall survival and explore risk progression-free survival in ENKTL, and establish a prognostic predictive nomogram for ENKTL patients.
Detailed description
This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL between January 1, 2000 and August 31, 2020; (2) Patients older than 18 years. The pathology of initial diagnosis was reviewed by designated pathologists.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020. |
| Validation Cohort | – | –Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients diagnosed with ENKTL, between January 1, 2000 and August 31, 2020; 2. Patients older than 18 years.
Key inclusion criteria (3 listed)
- Patients newly diagnosed with ENKTL
- Patients diagnosed between January 1, 2000 and August 31, 2020
- Patients older than 18 years
Key exclusion criteria (1 listed)
- Patients who did not have complete clinical information or immunohistochemistry, or who were lost follow-up immediately after treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 year
Time between the date of diagnosis and any kinds of death
1 secondary outcome
Progression-free survival
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
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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.
Hua Wang principal investigator
Sun Yat-sen University
1 site 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, run by Sun Yat-sen University at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Wang (+862087342462, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 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 18 Jun 2023.