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
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
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
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
