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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046573
Receipt No. 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 2022/01/07

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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
Email 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
Email ikeda.daisuke@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

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
Email 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 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
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

Other
Other related information

Management information
Registered date
2022 Year 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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