UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015864 |
|---|---|
| Receipt number | R000018460 |
| Scientific Title | The analysis of the host genetic and viral pathological factors causing severe Enterovirus infection |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2021/12/14 14:40:55 |
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Basic information
Public title
The analysis of the host genetic and viral pathological factors causing severe Enterovirus infection
Acronym
The host genetic and viral factors related to Enterovirus infection
Scientific Title
The analysis of the host genetic and viral pathological factors causing severe Enterovirus infection
Scientific Title:Acronym
The host genetic and viral factors related to Enterovirus infection
Region
| Asia(except Japan) |
Condition
Condition
Hand, foot, and mouth disease
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the host genetic and viral factors of severe Enterovirus infection
Basic objectives2
Others
Basic objectives -Others
Clinical epidemiological surveillance
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The full genome and amino acids sequence of the isolated EV71 strains
Key secondary outcomes
1) The virological characteristics of the isolated EV71 strains
2) The demographics of the participants
3) The levels of cytokines and catecholamine among EV71 infected individuals
4) The type of HLA-A allele among EV71-infected individuals
5) SNPs of host genome
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) Severe HFMD cases:
1. Clinically diagnosed as HFMD grade II, III, or IV
2. The children requiring hospitalization.
(2) Mild HFMD cases:
1. Clinically diagnosed as HFMD grade I
2. The children NOT requiring hospitalization
Key exclusion criteria
The children whose family/guardian decline to participate to the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | ICHIMURA |
Organization
Graduate school of Medical Sciences, Kanazawa University
Division name
Department of Viral infection and International Health
Zip code
9208640
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL
076-265-2229
ichimura@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | ICHIMURA |
Organization
Graduate school of Medical Sciences, Kanazawa University
Division name
Department of Viral infection and International Health
Zip code
9208640
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8640, Japan
TEL
076-265-2229
Homepage URL
ichimura@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Graduate school of Medical Sciences, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital of Pediatrics, Hanoi, Vietnam
Tokyo Metropolitan Institute of Medical Science
Saitama Medical University, Research center for genomic medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1, Takara-machi, Kanazawa-shi, Ishikawa, 920-8641, Japan
Tel
076-265-2090
crc.irb-knz@esct.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
ベトナム国・ハノイ市国立小児病院
(National Hospital of Pediatrics, Hanoi, Vietnam)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 05 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Compare the relationship between the disease severity and the host and viral factors.
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018460
