UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016177 |
|---|---|
| Receipt number | R000018780 |
| Scientific Title | Human genome analysis project to identify risk factors of HBV reactivation following rituximab plus steroids containing chemotherapy (C-SHOT1402) |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2022/08/22 09:27:08 |
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Basic information
Public title
Human genome analysis project to identify risk factors of HBV reactivation following rituximab plus steroids containing chemotherapy (C-SHOT1402)
Acronym
Genetic analysis of HBV reactivation after rituximab therapy (C-SHOT1402)
Scientific Title
Human genome analysis project to identify risk factors of HBV reactivation following rituximab plus steroids containing chemotherapy (C-SHOT1402)
Scientific Title:Acronym
Genetic analysis of HBV reactivation after rituximab therapy (C-SHOT1402)
Region
| Japan |
Condition
Condition
Malignant lymphoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify host risk factors associated with HBV reactivation using genetic analysis
Basic objectives2
Others
Basic objectives -Others
Genetic analysis
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Host risk factors for HBV reactivation
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria meet two either following:
1) A patient who was enrolled in the prospective study to prevent HBV reactivation using HBV DNA monitoring-guided preemptive antiviral therapy. (for an enrolled case for C-SHOT0802; UMIN000001299)
2) A HBsAg-negative patient with malignant lymphoma who was diagnosed as having HBV reactivation following rituximab plus steroid containing chemotherapy as an initial treatment. (if a non-enrolled case for C-SHOT0802)
Key exclusion criteria
1)younger than 19 years old
2)not ability for enough judgement even if 20 years old or older
3) not consciousness even if 20 years old or older
4) careful consideration for the notice of illness is necessary
5) Other conditions considered inappropriate by a physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Mizokami/Katsushi Tokunaga |
Organization
National Center for Global Health and Medicine/University of Tokyo
Division name
The Research Center for Hepatitis and Immunology/Department of Human Genetics
Zip code
Address
1-7-1 Kohnodai, Ichikawa, Chiba, 272-8516, Japan/7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
TEL
047-372-3501
mmizokami@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Kusumoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Hematology and Oncology
Zip code
Address
1 Kawasumi, Mizuho-chou, Mizuho-ku, Nagoya, 467-8601, Japan
TEL
052-853-8738
Homepage URL
skusumot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine/Department of Human Genetics, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NPO Center for Supporting Hematology-Oncology Trials (C-SHOT)
SRL,Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構 北海道がんセンター（北海道）
手稲渓仁会病院（北海道）
特定医療法人北楡会 札幌北楡病院（北海道）
東北大学病院（宮城県）
群馬大学医学部附属病院（群馬県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
国立がん研究センター東病院（千葉県）
埼玉医科大学国際医療センター包括的がんセンター（埼玉県）
神奈川県立がんセンター（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
東海大学医学部附属病院（神奈川県）
NTT東日本 関東病院（東京都）
東京慈恵会医科大学附属病院（東京都）
国立病院機構 災害医療センター（東京都）
東京慈恵会医科大学附属第三病院（東京都）
東京都立駒込病院（東京都）
埼玉県立がんセンター（埼玉県）
横浜市立大学附属病院（神奈川県）
名古屋第二赤十字病院（愛知県）
愛知県がんセンター中央病院（愛知県）
名古屋市立大学病院（愛知県）
豊田厚生病院（愛知県）
国立病院機構 名古屋医療センター（愛知県）
名古屋大学医学部附属病院（愛知県）
浜松医科大学医学部附属病院（静岡県）
名古屋記念病院（愛知県）
小牧市民病院（愛知県）
三重大学医学部附属病院（三重県）
愛知医科大学付属病院（愛知県）
名古屋市立西部医療センター（愛知県）
藤田保健衛生大学病院（愛知県）
福井大学医学部附属病院（福井県）
金沢医科大学病院（石川県）
滋賀県立成人病センター（滋賀県）
大阪市立大学医学部附属病院（大阪府）
兵庫県立がんセンター（兵庫県）
倉敷中央病院（岡山県）
岡山大学病院（岡山県）
島根大学医学部附属病院（島根県）
国立病院機構九州がんセンター（福岡県）
大分県立病院（大分県）
佐賀大学附属病院（佐賀県）
熊本大学医学部（熊本県）
国立病院機構 熊本医療センター（熊本県）
佐世保市立総合病院（長崎県）
長崎大学病院（長崎県）
国立病院機構 長崎医療センター（長崎県）
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 14 | Day |
Other
Other related information
Identification of host risk factors associated with HBV reactivation using genetic analysis including genome-wide analysis.
Management information
Registered date
| 2015 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018780
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
