UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of elderly patients with classical Hodgkin lymphoma in Japan: HORIZON study
Acronym	Retrospective study for elderly Hodgkin lymphoma: (HORIZON study)
Scientific Title	Retrospective study of elderly patients with classical Hodgkin lymphoma in Japan: HORIZON study
Scientific Title:Acronym	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) 5-year event-free survival rate 3) Overall response rate and complete response rate of first-line therapy 4) The rate of bleomycin lung toxicity (BLT) 5) The rate of patients who completed 100%-dose ABVD therapy 6) The average relative dose-intensity of ABVD therapy 7) Charlson Comorbidity Index (CCI) score at the baseline 8) 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	1st name Hirokazu Middle name Last name Nagai
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Hematology
Zip code	460-0001
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	1st name Shinichi Middle name Last name Makita
Organization	National Cancer Center Hospital
Division name	Department of Hematology
Zip code	104-0045
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)

IRB Contact (For public release)
Organization	National Hospital Organization Nagoya Medical Center
Address	4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan
Tel	+81-52-951-1111
Email	nmc-rec@nnh.hosp.go.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

Sapporo Hokuyu Hospital (Hokkaido) National Hospital Organization Hokkaido Cancer Center (Hokkaido) Iwate Medical University Hospital (Iwate) Tohoku University Hospital (Miyagi) Akita University Hospital (Akita) Gunma Prefectural Cancer Center (Gunma) Fujioka General Hospital (Gunma) Saitama Medical University International Medical Center (Saitama) Saitama Medical Center (Saitama) Chiba Cancer Center (Chiba) National Cancer Center Hospital East (Chiba) National Cancer Center Hospital (Tokyo) The Jikei University Hospital (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) 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) 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) Gunma University Hospital (Gunma) Osaka City general Hospital (Osaka)

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

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications	https://ash.confex.com/ash/2021/webprogram/Paper146340.html
Number of participants that the trial has enrolled	171
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	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 05 Month 15 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2023 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037927