UMIN-CTR Clinical Trial

Basic information
Public title	Characteristics and prognosis of COVID-19 patients with hematological diseases in Japan
Acronym	JSH-COVID19-20
Scientific Title	Characteristics and prognosis in COVID-19 patients with hematologic diseases in Japan: a cross-sectional study
Scientific Title:Acronym	JSH-COVID19-20
Region	Japan

Condition
Condition	Hematological diseases, coronavirus disease 2019
Classification by specialty	Hematology and clinical oncology Infectious disease
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Since the global COVID-19 pandemic began at the end of 2019, reports from other countries state that patients with hematological diseases have a poor prognosis. Thus, this study aims to examine the characteristics and prognosis of COVID-19 patients with hematologic diseases in Japan.
Basic objectives2	Others
Basic objectives -Others	This study is a cross-sectional study on characteristics and prognosis of COVID-19 patients with hematological diseases in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of characteristics and short-term prognosis of COVID-19 patients with hematological diseases in Japan
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who have been registered or will be registered in the future into the Epidemiological Survey "Hematological Disease Registration" in the Japanese Society of Hematology (2) Patients who were diagnosed as COVID19 infection (SARS-CoV-2 PCR-positive or antigen-positive), and whose prognosis up to 2 months after diagnosis has been fixed. (Suspected patients in imaging or antibody test are not included.)
Key exclusion criteria	(1) When the subject is judged inappropriate in this study by the principal investigator or subinvestigators. (2) When the subject or his/her substitute requests to decline the research cooperation.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kinuko Middle name Last name Mitani
Organization	Dokkyo Medical University
Division name	Department of Hematology and Oncology
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293, Japan
TEL	0282-86-1111
Email	mitanik@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Minakata
Organization	Jichi Medical University
Division name	Division of Hematology
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke-shi,Tochigi,329-0498, Japan
TEL	0285-58-7353
Homepage URL
Email	daisuke_minakata_kappa@yahoo.co.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Japanese Society of Hematology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Public Health Research Foundation
Address	1-1-7 Nishiwaseda Shinjuku-ku Tokyo, 169-0051, Japan
Tel	03-5287-5070
Email	rinri@phrf.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 05 Month 19 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	Preinitiation
Date of protocol fixation	2021 Year 04 Month 16 Day
Date of IRB	2021 Year 04 Month 19 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Several reports on COVID19 infection in patients with hematological diseases have been published from other countries (China, USA, and European countries) Fatality rate in these patients tends to be higher than in patients without a specific disease background. There exists no report on patients with benign or malignant hematological diseases in Japan. The Japanese Society of Hematology (JSH) considers that collecting and analyzing these data will be useful for the treatment of hematological diseases under a circumstance of this COVID-19 pandemic.

Management information
Registered date	2021 Year 05 Month 19 Day
Last modified on	2021 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049979