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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name