UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045267 |
|---|---|
| Receipt number | R000051706 |
| Scientific Title | Evaluation of clinical efficacy of COVID-19 vaccination in patients with hematological diseases. |
| Date of disclosure of the study information | 2021/08/26 |
| Last modified on | 2023/09/07 17:17:33 |
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Basic information
Public title
Evaluation of clinical efficacy of COVID-19 vaccination in patients with hematological diseases.
Acronym
Evaluation of clinical efficacy of COVID-19 vaccination in patients with hematological diseases.
Scientific Title
Evaluation of clinical efficacy of COVID-19 vaccination in patients with hematological diseases.
Scientific Title:Acronym
Evaluation of clinical efficacy of COVID-19 vaccination in patients with hematological diseases.
Region
| Japan |
Condition
Condition
hematological diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical efficacy of COVID-19 vaccination in patients with hematological diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of SARS-COV2 spike protein seropositivity at 2w, 3m, 6m, 9m and 12m after vaccination.
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
Patients with hematological diseases, who are treated or followed at Aiiku Hospital.
Key exclusion criteria
Patients who are judged to be ineligible for the study.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
064-0804
Address
2-1 S4 W25 Chuo-ku, Sapporo
TEL
+81-11-563-2211
kondo@aiiku-hp.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
064-0804
Address
2-1 S4 W25 Chuo-ku, Sapporo
TEL
+81-11-563-2211
Homepage URL
kondo@aiiku-hp.or.jp
Sponsor or person
Institute
Blood Disorders Center, Aiiku Hospital
Institute
Department
Personal name
Funding Source
Organization
Blood Disorders Center, Aiiku Hospital
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
Aiiku Hospital Ethical Committee
Address
2-1 S4 W25 Chuo-ku, Sapporo
Tel
+81-11-563-2211
aiiku-rinri@aiiku-hp.or.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 | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://aiiku-hp.or.jp/m/department/ketsueki_center/
Number of participants that the trial has enrolled
660
Results
Ann Hematol. 2023 Jun;102(6):1421-1431. doi: 10.1007/s00277-023-05204-7.
Ann Hematol. 2023 Apr;102(4):819-827. doi: 10.1007/s00277-023-05142-4.
Br J Haematol. 2023 Mar;200(6):717-721. doi: 10.1111/bjh.18578.
Br J Haematol. 2022 Nov;199(4):627-630. doi: 10.1111/bjh.18447.
Br J Haematol. 2022 Jun;197(6):691-696. doi: 10.1111/bjh.18138.
Results date posted
| 2023 | Year | 09 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 02 | Month | 28 | 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 | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051706
