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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046096
Receipt No. 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 2021/11/17

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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
Email 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
Email afujimot@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

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
Email 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 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
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
2024 Year 03 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
2021 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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