UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044254 |
|---|---|
| Receipt number | R000049979 |
| Scientific Title | Characteristics and prognosis in COVID-19 patients with hematologic diseases in Japan: a cross-sectional study |
| Date of disclosure of the study information | 2021/05/19 |
| Last modified on | 2021/05/24 16:50:24 |
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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
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
daisuke_minakata_kappa@yahoo.co.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049979
| Research Plan | |
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| Registered date | File name |
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