UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002956
Receipt number 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 18:22:11

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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 or person

Institute

Department of Pedistrics, Gifu University

Institute

Department

Personal name



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

Value
https://center6.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