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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002926
Receipt No. R000003555
Scientific Title Prediction and prognosis of allergic and immunologic disease in children by birth cohort study
Date of disclosure of the study information 2009/12/22
Last modified on 2018/12/30

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Basic information
Public title Prediction and prognosis of allergic and immunologic disease in children by birth cohort study
Acronym Gifu Allergy and Immunology Cohort Study (GAICS)
Scientific Title Prediction and prognosis of allergic and immunologic disease in children by birth cohort study
Scientific Title:Acronym Gifu Allergy and Immunology Cohort Study (GAICS)
Region
Japan

Condition
Condition Allergic disease in Children (Atopic dermatitis, Recurrent Wheezing, Bronchial asthma, Food Allergy, Pet Allergy etc.)
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The mechanisms of developing allergic disease in childhood were unclear. We will evaluate the genetic factors, environmental factors (such as maternal environment during pregnancy, type and duration of feeding, food, living environment, pet ownership or inflectional disease etc.) to investigate what kind of factors are affecting to develop allergic disease in childhood.
Basic objectives2 Others
Basic objectives -Others Diagnosis of Allergic diseases (such as Atopic dermatitis, Recurrent Wheezing, Bronchial asthma, Food Allergy, Pet Allergy etc.) by questionnaire or physical examination, and evaluation of sensitization by blood test (such as specific IgE etc.)
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Pathogenesis of allergic disease in children (Atopic Dermatitis, Recurrent Wheezing, Bronchial Asthma, Food Allergy, Pet Allergy), Specific-IgE positive.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Newborn infants born in a maternity hospital were recruited. The details of this cohort study were explained to the parent(s) before birth, and those who consented with written agreement participated.
Key exclusion criteria None
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Kondo
Organization Gifu University, Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-1 Yanagido, Gifu City, Gifu Prefecture, Japan
TEL 058-230-6386
Email noriok-gif@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Kawamoto
Organization Gifu University, Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-1 Yanagido Gifu 501-1194, Japan
TEL +81-58-230-6000
Homepage URL
Email noriok-gif@umin.ac.jp

Sponsor
Institute Gifu University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Health and Labor Science Research Grants for Research on Allergic Disease and Immunology from the Ministry of Health, Labor and Welfare, Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2009 Year 12 Month 22 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 No longer recruiting
Date of protocol fixation
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 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 will evaluate the genetic factors, environmental factors (such as maternal environment during pregnancy, type and duration of feeding, food, living environment, pet ownership or inflectional disease etc.) to investigate what kind of factors are affecting to develop allergic disease in childhood.

Management information
Registered date
2009 Year 12 Month 22 Day
Last modified on
2018 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=R000003555

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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