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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002956
Receipt No. R000003597
Scientific Title Prediction and prevention of asthma onset by the analysis of the environmental and genetic factors
Date of disclosure of the study information 2010/03/01
Last modified on 2009/12/30

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Basic information
Public title Prediction and prevention of asthma onset by the analysis of the environmental and genetic factors
Acronym Prediction and prevention of asthma onset
Scientific Title Prediction and prevention of asthma onset by the analysis of the environmental and genetic factors
Scientific Title:Acronym Prediction and prevention of asthma onset
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Based on the analysis of the environmental and genetic factors, we advise the parents to modify their environment, for example, avoiding the pet. We try to prevent their onset of bronchial asthma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Based on the analysis of the information of environmental and genetic factors, whether the onset of bronchial asthma is prevented or not.
Key secondary outcomes

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
1 years-old <=
Age-upper limit
2 years-old >
Gender Male and Female
Key inclusion criteria Environmental and genetic factots for asthma onset were checked at 18 month.
The children who have the risk factors of asthma onset were advised by the pediatrician.
Key exclusion criteria The childeren who have not assent to this study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Kondo
Organization Graduate School of Medicine, Gifu University
Division name Department of Pediatrics
Zip code
Address 1-1 Yanagido, Gifu
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Gifu University
Division name Department of Pediatrics
Zip code
Address
TEL
Homepage URL
Email hideo@gifu-u.ac.jp

Sponsor
Institute Department of Pedistrics, Gifu University
Institute
Department

Funding Source
Organization The Environmental Restoration and Conservation Agency of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze the questionnaire about the environmental and genetic factors for the onset of bronchial asthma.

Management information
Registered date
2009 Year 12 Month 30 Day
Last modified on
2009 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003597

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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