UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052145 |
|---|---|
| Receipt number | R000059515 |
| Scientific Title | Treatment for hematological diseases and its effect to anti-SARS-CoV-2 antibody. |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2023/09/07 18:15:02 |
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Basic information
Public title
Evaluation of anti-SARS-CoV-2 antibody in patients with hematological diseases who receive treatment after vaccination.
Acronym
Treatment for hematological diseases and its effect to anti-SARS-CoV-2 antibody.
Scientific Title
Treatment for hematological diseases and its effect to anti-SARS-CoV-2 antibody.
Scientific Title:Acronym
Treatment for hematological diseases and its effect to anti-SARS-CoV-2 antibody.
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 effect of treatment for hematological diseases on anti-SARS-CoV-2 antibody titer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of anti-SARS-COV-2 antibody at baseline, 6m, 12m and 18m after treatment for hematological diseases.
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
1) Patients with hematological diseases.
2) Patients who have received more than 3 times of vaccination before onset of hematological diseases.
3) Patients who will undergo treatment for hematological diseases.
4) Healthy volunteers who have received more than 3 times of vaccinationn and don' t receive immunosuppressive therapy.
Key exclusion criteria
Patients who are judged to be ineligible for the study.
Target sample size
500
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
Self funding
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
| 2023 | Year | 09 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | 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=R000059515
