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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023742
Receipt No. R000027342
Scientific Title Study of factors of virus and host sassociated with severe Enterovirus diseases
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/24

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Basic information
Public title Study of factors of virus and host sassociated with severe Enterovirus diseases
Acronym Study of severe Enterovirus diseases
Scientific Title Study of factors of virus and host sassociated with severe Enterovirus diseases
Scientific Title:Acronym Study of severe Enterovirus diseases
Region
Japan

Condition
Condition Enterovirus71 infection
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to identify that factors of virus and host associated with severe Enterovirus71 diseases.
Basic objectives2 Others
Basic objectives -Others virology
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of virus factor associated with severe Enterovirus71 diseases
Key secondary outcomes Etiology of Enterovirus71 infection

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
0 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Patients detected Enterovirus in blood or cerebrospinal fluid
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuho Horikoshi
Organization Tokyo Metropolitan Children's Medical Center
Division name infectious diseases
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 0423005111
Email yuho71@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mihoko Isogai
Organization Tokyo Metropolitan Children's Medical Center
Division name infectious diseases
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL 0423005111
Homepage URL http://www.byouin.metro.tokyo.jp/shouni/tiken/rinshou_shounin.html
Email mihoko.isogai@gmail.com

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Metropolitan Institute of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京都立小児総合医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2026 Year 06 Month 30 Day
Date of closure to data entry
2026 Year 07 Month 31 Day
Date trial data considered complete
2027 Year 07 Month 31 Day
Date analysis concluded
2028 Year 03 Month 31 Day

Other
Other related information Years, Sex, Body weight, underling diseases, labodata, vital signs, result of PCR

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2016 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027342

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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