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
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
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
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
