UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046573 |
|---|---|
| Receipt number | R000053118 |
| Scientific Title | Study on the dynamics of antibody titer after SARS-CoV2 vaccination in patients with hematological tumors |
| Date of disclosure of the study information | 2022/01/07 |
| Last modified on | 2023/07/23 19:31:02 |
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Basic information
Public title
Study on the dynamics of antibody titer after SARS-CoV2 vaccination in patients with hematological tumors
Acronym
Study on the dynamics of antibody titer after SARS-CoV2 vaccination in patients with hematological tumors
Scientific Title
Study on the dynamics of antibody titer after SARS-CoV2 vaccination in patients with hematological tumors
Scientific Title:Acronym
Study on the dynamics of antibody titer after SARS-CoV2 vaccination in patients with hematological tumors
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of disease and treatment-induced immune compromise on antibody production following vaccination against novel coronaviruses in patients with hematologic malignancies.
Basic objectives2
Others
Basic objectives -Others
Efficacy of booster vaccination
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Antibody titer measured at each time point in the case group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
In the case group, additional blood samples will be taken during routine blood collection for antibody titer measurement.
Interventions/Control_2
In the control group, a new blood sample will be drawn for antibody titer measurement.
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
The case group consists of 1) those who are attending or hospitalized in the Department of Hematology/Oncology of our hospital, 2) those who have completed two doses of regular mRNA vaccination by December 1, 2021, and 3) those who have given written consent by themselves or a substitute who fully understands this study.
The control group consisted of 1) those who had completed two doses of regular mRNA vaccination by December 1, 2021, and 2) those who had given written consent by themselves or a substitute who fully understood this study.
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
1) If the researcher cannot obtain written consent for participation in the research from an individual or a substitute, 2) If an individual is under 20 years of age, or 3) If the principal investigator and subcontractors determine that an individual is ineligible for the research.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikeda |
Organization
Kameda Medical Center
Division name
Division of Hematology/Oncology
Zip code
2968602
Address
929, Higashi-chou, Kamogawa, Chiba, Japan
TEL
+81-04-7092-2211
ikeda.daisuke@kameda.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikeda |
Organization
Kameda Medical Center
Division name
Division of Hematology/Oncology
Zip code
2968602
Address
929, Higashi-chou, Kamogawa, Chiba, Japan
TEL
+81-04-7092-2211
Homepage URL
ikeda.daisuke@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center, Research Ethics Committee
Address
929 Higashi-cho,Kamogawa City,Chiba Prefecture,Japan 296-8602
Tel
04-7092-2211
clinical_research@kameda.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1111/bjh.18549
Number of participants that the trial has enrolled
544
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 07 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053118
