UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045150 |
|---|---|
| Receipt number | R000051578 |
| Scientific Title | Investigation of changes in blood antibody titer caused by COVID-1.9 vaccination in patients with hematological disorders |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2021/08/13 14:19:15 |
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Basic information
Public title
Investigation of changes in blood antibody titer caused by COVID-1.9 vaccination in patients with hematological disorders
Acronym
Study of Antibody Titer of COVID-19 Vaccine in Hematological Disorders
Scientific Title
Investigation of changes in blood antibody titer caused by COVID-1.9 vaccination in patients with hematological disorders
Scientific Title:Acronym
Study of Antibody Titer of COVID-19 Vaccine in Hematological Disorders
Region
| Japan |
Condition
Condition
Hematological Disorders
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the rate of antibody acquisition and the duration of antibodies by the COVID-19 vaccine in patients with hematological diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of antibody acquisition for each hematological disorders.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with hematological disorders and healthy volunteers with consent.
Key exclusion criteria
none
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Tomita |
Organization
Fujita Health University School of Medicine
Division name
Department of Hematology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562-93-9243
atomita@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Akinao |
| Middle name | |
| Last name | Okamoto |
Organization
Fujita Health University School of Medicine
Division name
Department of Hematology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
TEL
0562-93-9243
Homepage URL
aokamoto@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
Fujita Health University School of Medicine
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake
Tel
0562-93-9243
aokamoto@fujita-hu.ac.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
| 2021 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Antibody titers in patients with hematological diseases will be observed over time after vaccination.
Management information
Registered date
| 2021 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051578
