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
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
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
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
