UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023742
Receipt number 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 10:24:36

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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 or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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

Value
https://center6.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