UMIN-CTR Clinical Trial

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
Institute	Fujita Health University School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051578