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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name