UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053399 |
|---|---|
| Receipt number | R000060943 |
| Scientific Title | Analysis of human genetic factors determining anti-HBV immune response to HBV reactivation or HB vaccine after allogeneic hematopoietic cell transplantation |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2024/07/21 09:22:52 |
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Basic information
Public title
Analysis of human genetic factors determining anti-HBV immune response to HBV reactivation or HB vaccine after allogeneic hematopoietic cell transplantation
Acronym
HBV response
Scientific Title
Analysis of human genetic factors determining anti-HBV immune response to HBV reactivation or HB vaccine after allogeneic hematopoietic cell transplantation
Scientific Title:Acronym
HBV response
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study is conducted as an ancillary research of the previous study, "Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity (PREVENT HBV)" (UMIN000034113)
In this ancillary research, we investigated the correlation between immune responsiveness of HBs antibody titer and genetic factors of donor cells in cases of HBV reactivation and cases completed 3 doses of HB vaccine among participants of the PREVENT HBV study.
Basic objectives2
Others
Basic objectives -Others
Comparison of immune response between the SARS-CoV2 vaccine and HB vaccine
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of immunological response against post-transplant HBV reactivation and HB vaccine by donor cell genetic factors.
Determine whether immune response against HBV reactivation after allogeneic hematopoietic cell transplantation and HB vaccine are affected by HLA type, BTNL2 genetic polymorphism, etc.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Cases with HBV reactivation in the main study
2) Cases who were assigned to the HB vaccine group in the main study and completed three doses of HB vaccine
Cases that meet 1) or 2)
Key exclusion criteria
None
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Mizokami |
Organization
National Center for Global Health and Medicine
Division name
Genome Medical Sciences Project
Zip code
272-8516
Address
1-7-1, Konodai, Ichikawa, Chiba
TEL
047-372-3501
mmizokami@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Onozawa |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7214
Homepage URL
onozawa@med.hokudai.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Aichi Cancer Center
Address
1-1 Kakodono, Chikusa-ku, Nagoya
Tel
052-762-6111
irb-jimu@aichi-cc.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
北海道大学病院(北海道)、札幌北楡病院(北海道)、東北大学病院(宮城県)、神奈川県立がんセンター(神奈川県)、自治医科大学附属病院(栃木県)、東京都立駒込病院(東京都)、安城更生病院(愛知県)、江南厚生病院(愛知県)、京都大学医学部附属病院(京都府)、近畿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)、佐世保市総合医療センター(長崎県)、熊本大学医学部附属病院(熊本県)、慈愛会今村総合病院(鹿児島県)、鹿児島大学病院(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 01 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060943
