UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056213 |
|---|---|
| Receipt number | R000064193 |
| Scientific Title | International ENKL project 2025 |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 14:36:11 |
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Basic information
Public title
International Collaborative Study of Newly Diagnosed Extranodal NK/T-Cell Lymphoma Patients diagnosed between 2014 and 2021 -International ENKL project 2025-
Acronym
International ENKL project 2025
Scientific Title
International ENKL project 2025
Scientific Title:Acronym
ENKL2025
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
Condition
Condition
newly diagnosed extranodal NK/T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to understand the actual conditions of patients diagnosed with extranodal NK/T-cell lymphoma (ENKL) both domestically and internationally from January 1, 2014, to December 31, 2021, as well as to analyze treatments, their effectiveness, and prognostic factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To understand the demographics in each country
2. To assess the trend of prognosis and treatment
3. To evaluate prognostic factors and treatment response
4. Finally, to elucidate the best management of ENKL patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases of ENKL diagnosed from January 1, 2014, to December 31, 2021, at participating institutes in this study will be included.
Key exclusion criteria
1. Case which diagnosis is not matched with the diagnostic criteria of extranodal NK/T-cell lymphoma suggested in WHO classification.
2. Case which is withdrawn to register this study.
Target sample size
568
Research contact person
Name of lead principal investigator
| 1st name | Ritsuro |
| Middle name | |
| Last name | Suzuki |
Organization
Department of Internal Medicine, Faculty of Medicine, Shimane University
Division name
Division of Hematology and Oncology
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Japan
TEL
0853-20-2308
rsuzuki@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Department of Internal Medicine, Faculty of Medicine, Shimane University
Division name
Division of Hematology and Oncology
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Japan
TEL
0853-20-2308
Homepage URL
afujimot@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital
Address
89-1 Enya-cho, Izumo, Japan
Tel
0853202515
kenkyu@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the NKEA-Next participating institutes in Japan that agreed to participate in this study, patient data collected in NKEA-Next will also be used in this study, with no additional patients collected. For institutes in Japan and other countries and regions outside of the NKEA-Next participating institutions that agreed to participate in this study, case report forms will be collected. Cases included in overseas registry database will also be included in the study.
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064193
