UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033264
Receipt number R000037927
Scientific Title 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 2022/07/08 18:42:39

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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 or person

Institute

HORIZON study investigators

Institute

Department

Personal name



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

Value
https://center6.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