UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046096 |
|---|---|
| Receipt number | R000052176 |
| Scientific Title | Nationwide Survey of Aggressive NK-cell leukemia: multi-center retrospective study in Japan |
| Date of disclosure of the study information | 2021/11/17 |
| Last modified on | 2024/05/20 09:11:52 |
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Basic information
Public title
Nationwide Survey of Aggressive NK-cell leukemia: multi-center retrospective study in Japan
Acronym
ANKL22
Scientific Title
Nationwide Survey of Aggressive NK-cell leukemia: multi-center retrospective study in Japan
Scientific Title:Acronym
ANKL22
Region
| Japan |
Condition
Condition
Aggressive NK-cell leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify the probability, patient characteristics, treatment and prognosis of patients with aggressive NK-cell leukemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Progression-free survival (PFS)
/Overall response rate, complete response rate, best overall response, OS, PFS, duration of response (DOR) of patients who received chemotherapy or stem cell transplantation
/Risk factors on survival time
/To establish a database of patients with aggressive NK-cell leukemia by integrating with the ANKL07 database
/To analyze a transition of probability, patient characteristics, treatment, and prognosis
/To compare patient characteristics, treatment, response rate, prognosis of patients with extranodal NK-cell lymphoma, nasal type and aggressive NK-cell leukemia
/Genome analysis of aggressive NK-cell leukemia
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
| 1 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ANKL cases including those transformed from chronic active Epstein-Barr virus infection or chronic NK-cell lymphoproliferative disease, diagnosed between January 1985 and December 2021. The diagnosis is based on WHO classification revised 4th edition.
Key exclusion criteria
Case which diagnosis is not matched with the diagnostic criteria of aggressive NK-cell leukemia suggested in WHO classification
/Case which is withdrawn to register this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ritsuro |
| Middle name | |
| Last name | Suzuki |
Organization
Shimane University
Division name
Department of Hematology and Oncology
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Japan
TEL
0853-20-23088
rsuzuki@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Fujimoto |
Organization
Shimane University Hospital
Division name
Department of Hematology
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Japan
TEL
0853-20-23088
Homepage URL
afujimot@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
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
0853-20-2308
afujimot@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
| 2021 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://ashpublications.org/blood/article/140/Supplement%201/9435/487978/Improving-Prognosis-of-Aggr
Number of participants that the trial has enrolled
108
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Nationwide Survey of Aggressive NK-cell leukemia: multi-center retrospective study
Management information
Registered date
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052176
