|
UMIN-CTR Clinical Trial |
|
 UMIN-CTR English Home |
Glossary (Simple) |
FAQ |
Search clinical trials |
| 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 |
| 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 |
|
|
| Condition | ||
| Condition | Classical Hodgkin lymphoma | |
| Classification by specialty |
|
|
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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 |
| 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 | |
| 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 |
|
||||||
| Progress | |||||||
| Recruitment status | Preinitiation | ||||||
| Date of protocol fixation |
|
||||||
| Anticipated trial start date |
|
||||||
| 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 |
|
||||||
| Last modified on |
|
||||||
| 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 |
