UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Next-Generation Therapy for NK/T-cell lymphoma in East Asia: a multi-institutional retrospective study
Title of the study (Brief title)	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	Motoko yamaguchi
Organization	Mie University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	+81-59-231-5016
Email	waniwani@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Motoko Yamaguchi
Organization	Mie University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	+81-59-231-5016
Homepage URL
Email	waniwani@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Hematology and Oncology, Mie University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://ascopubs.org/doi/full/10.1200/JCO.2016.68.1619
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018002