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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033264
Receipt No. R000037927
Official scientific title of the study Retrospective study of elderly patients with classical Hodgkin lymphoma in Japan: HORIZON study
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/04

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Basic information
Official scientific title of the study Retrospective study of elderly patients with classical Hodgkin lymphoma in Japan: HORIZON study
Title of the study (Brief title) Retrospective study for elderly Hodgkin lymphoma: (HORIZON study)
Region
Japan

Condition
Condition Classical Hodgkin lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore retrospectively the clincopathological characteristics, clinical outcomes, and treatment toxicities in elderly patients with classical Hodgkin lymphoma in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 5-year overall survival rate
Key secondary outcomes 1) 5-year progression-free survival rate
2) Overall response rate and complete response rate of first-line therapy
3) The rate of bleomycin lung toxicity (BLT)
4) The rate of patients who completed 100%-dose ABVD therapy
5) The average relative dose-intensity of ABVD therapy
6) Charlson Comorbidity Index (CCI) score at the baseline
7) Investigation of pathological biomarkers

Base
Study type Others,meta-analysis etc

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
61 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients who were histologically diagnosed as having classical Hodgkin lymphoma (cHL) based on WHO classification 2017 at the institution from January 2007 to December 2016.
2) The age at the diagnosis of classic Hodgkin lymphoma was 61 years old or older.
Key exclusion criteria 1) Positive for HIV
2) Patients who received first-line treatment outside the study institution
3) Patients who were not treated or managed by the hematologists in each study institution (ex. Second opinion)
4) Patients who were diagnosed as having methotrexate-associated lymphoproliferative disorders.
Target sample size 300

Research contact person
Name of lead principal investigator Hirokazu Nagai
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Hematology
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan
TEL +81-52-951-1111
Email nagaih@nnh.hosp.go.jp

Public contact
Name of contact person Shinichi Makita
Organization National Cancer Center Hospital
Division name Department of Hematology
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL +81-3-3542-2511
Homepage URL
Email smakita@ncc.go.jp

Sponsor
Institute HORIZON study investigators
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development: Practical Research for Innovative Cancer Control
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Cancer Center Research and Development fund (29-A-3)
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 Sapporo Hokuyu Hospital (Hokkaido)
National Hospital Organization Hokkaido Cancer Center (Hokkaido)
Iwate Medical University Hospital (Iwate)
Tohoku University Hospital (Miyagi)
Akita University Hospital (Akita)
Yamagata University Hospital (Yamagata)
Gunma Prefectural Cancer Center (Gunma)
Fujioka General Hospital (Gunma)
Saitama Medical University International Medical Center (Saitama)
Saitama Medical Center (Saitama)
Saitama Cancer Center (Saitama)
Chiba Cancer Center (Chiba)
National Cancer Center Hospital East (Chiba)
National Cancer Center Hospital (Tokyo)
The Jikei University Hospital (Tokyo)
NTT Medical Center Tokyo (Tokyo)
Kyorin University Hospital (Tokyo)
Jikei University, Daisan Hospital (Tokyo)
Kanagawa Cancer Center (Kanagawa)
Tokai University Hospital (Kanagawa)
Kanazawa Medical University (Ishikawa)
University of Fukui Hospital (Fukui)
National Hospital Organization Nagoya Medical Center (Aichi)
Aichi Cancer Center Hospital (Aichi)
Nagoya University Hospital (Aichi)
Japanese Red Cross Nagoya Daini Hospital (Aichi)
Nagoya City University Hospital (Aichi)
Toyota Kosei Hospital (Aichi)
Fujita Health University Hospital (Aichi)
Aichi Medical University Hospital (Aichi)
Mie University Hospital (Mie)
Shiga General Hospital (Shiga)
University Hospital, Kyoto Prefectural University of Medicine (Kyoto)
Kindai University Hospital (Osaka)
Hyogo Cancer Center (Hyogo)
Shimane University Hospital (Shimane)
National Hospital Organization Okayama Medical Center (Okayama)
Ehime University Hospital (Ehime)
Hospital of the University of Occupational and Environmental Health, Japan (Fukuoka)
National Hospital Organization Kyushu Medical Center (Fukuoka)
National Hospital Organization Kyushu Cancer Center (Fukuoka)
Fukuoka University Faculty of Medicine (Fukuoka)
Saga University Hospital (Saga)
The Japanese Red Cross Nagasaki Genbaku Hospital (Nagasaki)
Nagasaki University Hospital (Nagasaki)
National Hospital Organization Nagasaki Medical Center (Nagasaki)
Sasebo City General Hospital (Nagasaki)
Kumamoto University Hospital (Kumamoto)
Oita Prefectural Hospital (Oita)
Kagoshima University Hospital (Kagoshima)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 20 Day
Anticipated trial start date
2018 Year 08 Month 01 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 Unpublished
URL releasing results
Results
Other related information Not applicable

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037927

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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