UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000016177 |
| Receipt No. | 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 (Ver. 8) |
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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) | |
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| Condition | |||
| Condition | Malignant lymphoma | ||
| Classification by specialty |
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| 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 | |
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| Interventions/Control_3 | |
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| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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) |
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| 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 |
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| Target sample size | 200 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 | |
| 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 | |
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| 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 |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Unpublished |
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| IPD sharing Plan description | |
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | Identification of host risk factors associated with HBV reactivation using genetic analysis including genome-wide analysis. |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018780 |
