UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046300 |
|---|---|
| Receipt number | R000052827 |
| Scientific Title | Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multicenter retrospective study in Japan for the next step |
| Date of disclosure of the study information | 2021/12/07 |
| Last modified on | 2023/06/09 16:00:18 |
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Basic information
Public title
Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multicenter retrospective study in Japan for the next step
Acronym
NKEA-Next project
Scientific Title
Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multicenter retrospective study in Japan for the next step
Scientific Title:Acronym
NKEA-Next project
Region
| Japan |
Condition
Condition
Extranodal NK/T-cell lymphoma, nasal type (ENKL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the clinical features and current status of treatment in ENKL patients in Japan
To build an ENKL Japanese patient dataset that can be compared internationally in the future
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of ENKL patients who received next-generation treatment in 2014-2021 at participating institutes
Key secondary outcomes
1. Clinical features, treatment, toxicity profile, and risk factors affecting survival of ENKL patients who received next-generation treatment in 2014-2021 at participating institutes
2. Clinical features, treatment, toxicity profile, and prognosis of ENKL patients diagnosed in 2014-2021 at participating institutions and their annual transition
3. Construction of ENKL patient database combined with the dataset of NKEA Part A
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
Patients who meet either 1 or 2 below are eligible.
1. ENKL patients who were diagnosed between January 1, 2014 and December 31, 2021 at participating institutions
2. Patients who were enrolled in NKEA Part A
Key exclusion criteria
Patients with one or more of the following are excluded.
1. Patients who were diagnosed as not ENKL based on diagnosis-related information or central pathology review
2. Patients who refused to consent to opt-out
Target sample size
658
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-9072
myamaguchi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-9072
Homepage URL
myamaguchi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Committee of Malignant Lymphoma and Hematological Neoplasms, Japanese Radiation Oncology Study Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-231-5045
kk-sien@mo.medic.mie-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
北海道大学大学院医学研究院（北海道）
愛育病院（北海道）
東北大学病院（宮城県）
秋田大学大学院医学系研究科（秋田県）
獨協医科大学病院（栃木県）
群馬大学医学部附属病院（群馬県）
国立病院機構 渋川医療センター（群馬県）
埼玉県立がんセンター（埼玉県）
千葉県がんセンター（千葉県）
国立研究開発法人 国立がん研究センター中央病院（東京都）
東京慈恵会医科大学附属病院（東京都）
公益財団法人がん研究会有明病院（東京都）
東京都済生会中央病院（東京都）
日本大学医学部（東京都）
東海大学医学部付属病院（神奈川県）
神奈川県立がんセンター（神奈川県）
聖マリアンナ医科大学（神奈川県）
新潟大学大学院医歯学総合研究科（新潟県）
信州大学医学部附属病院（長野県）
金沢大学附属病院（石川県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
愛知県がんセンター病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部附属病院（愛知県）
愛知医科大学病院（愛知県）
藤田医科大学医学部（愛知県）
JA愛知厚生連豊田厚生病院（愛知県）
JA愛知厚生連海南病院（愛知県）
三重大学大学院医学系研究科（三重県）
京都府立医科大学大学院医学研究科（京都府）
京都第二赤十字病院（京都府）
神戸大学医学部附属病院（兵庫県）
兵庫県立がんセンター（兵庫県）
神戸市立医療センター中央市民病院（兵庫県）
神戸陽子線センター（兵庫県）
島根大学医学部附属病院（島根県）
岡山大学病院（岡山県）
川崎医科大学附属病院（岡山県）
公益財団法人 大原記念倉敷中央医療機構 倉敷中央病院（岡山県）
岡山赤十字病院（岡山県）
独立行政法人国立病院機構四国がんセンター（愛媛県）
独立行政法人国立病院機構 九州がんセンター（福岡県）
佐世保市総合医療センター（長崎県）
鹿児島大学大学院医歯学総合研究科（鹿児島県）
長野県立信州医療センター（長野県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 07 | 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
368
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 | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | 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
Other
Other related information
retrospective study
Management information
Registered date
| 2021 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052827
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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