UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015491 |
|---|---|
| Receipt number | R000018002 |
| Scientific Title | Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multi-institutional retrospective study |
| Date of disclosure of the study information | 2014/10/21 |
| Last modified on | 2018/10/24 09:11:29 |
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Basic information
Public title
Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multi-institutional retrospective study
Acronym
NKEA project
Scientific Title
Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multi-institutional retrospective study
Scientific Title:Acronym
NKEA project
Region
| Japan | Asia(except 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
Part A: To clarify the current situation of the treatment for ENKL in Japan
Part B: To construct a new prognostic model of ENKL among patients treated with next-generation therapy in Japan
Part C: To validate a new prognostic model of ENKL using clinical data on patients in East Asia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detailed information on treatment, clinical features and prognosis of patients with ENKL who were treated with next-generation therapy in Japan
Construct a prognostic model among patients with ENKL who were treated with next-generation therapy
Key secondary outcomes
Toxicity profile of next-generation therapy in Japan
Clinical features and prognosis of patients with ENKL who were diagnosed between 2000 and 2013 in Japan
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 with ENKL who were diagnosed between 2000 and 2013 in participating institutes
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
+81-59-231-5016
waniwani@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoko Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
+81-59-231-5016
Homepage URL
waniwani@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Oncology, Mie University Graduate School of Medicine
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
Japan
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
Address
Tel
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
東北大学病院（宮城県）
秋田大学医学部（秋田県）
群馬大学医学部附属病院（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
国立がん研究センター中央病院（東京都）
昭和大学病院（東京都）
がん研究会有明病院（東京都）
横浜市立大学附属病院（神奈川県）
東海大学医学部（神奈川県）
神奈川県立がんセンター（神奈川県）
新潟大学医歯学総合病院（新潟県）
長岡赤十字病院（新潟県）
金沢医科大学（石川県）
信州大学医学部（長野県）
長野県立須坂病院（長野県）
名古屋大学医学部（愛知県）
名古屋市立大学病院（愛知県）
豊田厚生病院（愛知県）
三重大学医学部（三重県）
滋賀県立成人病センター（滋賀県）
京都第二赤十字病院（京都府）
神戸大学医学部（兵庫県）
兵庫県立がんセンター（兵庫県）
奈良県立医科大学（奈良県）
鳥取県立中央病院（鳥取県）
島根大学医学部（島根県）
川崎医科大学（岡山県）
倉敷中央病院（岡山県）
国立病院機構九州がんセンター（福岡県）
佐賀大学医学部（佐賀県）
熊本市立熊本市民病院（熊本県）
サムスン医学センター（韓国）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://ascopubs.org/doi/full/10.1200/JCO.2016.68.1619
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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
