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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035836
Receipt No. R000040822
Scientific Title Investigation on the relation between prevalence of allergic conjunctivitis disease and environmental factors (Japan Environment and Children's Study cohort, Additional investigation in Kochi)
Date of disclosure of the study information 2019/03/27
Last modified on 2019/03/27

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Basic information
Public title Investigation on the relation between prevalence of allergic conjunctivitis disease and environmental factors (Japan Environment and Children's Study cohort, Additional investigation in Kochi)
Acronym prevalence of allergic conjunctivitis disease and environmental factors
Scientific Title Investigation on the relation between prevalence of allergic conjunctivitis disease and environmental factors (Japan Environment and Children's Study cohort, Additional investigation in Kochi)
Scientific Title:Acronym prevalence of allergic conjunctivitis disease and environmental factors
Region
Japan

Condition
Condition allergic conjunctivitis disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 prevalence of allergic conjunctivitis disease (Japan Environment and Children's Study cohort in Kochi) in children
Basic objectives2 Others
Basic objectives -Others Environmental factors in the development of allergic conjunctivitis disease (Japan Environment and Children's Study cohort in Kochi)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes prevalence of allergic conjunctivitis disease in children (Kochi)
Key secondary outcomes environmental factors
time- dependent changes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Total tear IgE test and Questionnaire (Japanese allergic conjunctival diseases Quality of Life Questionnaire (JACQLQ Ver.1)) survey will be performed on the test day
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
6 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Participate in the Japan Environment and Children's Study cohor at the Kochi Unit Center (detailed survey at the age of 6 years) and target those who have agreed to cooperate with this research
Key exclusion criteria Those who can not obtain cooperation consent for this research
Target sample size 246

Research contact person
Name of lead principal investigator
1st name Tamaki
Middle name
Last name Sumi
Organization Kochi Medical School
Division name ophthalmology
Zip code 783-8153
Address Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
TEL 088-880-2391
Email sumitama@kochi-u.ac.jp

Public contact
Name of contact person
1st name Tamaki
Middle name
Last name Sumi
Organization Kochi Medical School
Division name Ophthalmology
Zip code 783-8153
Address Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
TEL 088-880-2391
Homepage URL
Email sumitama@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Integrated Center for Advanced Medical Technologies
Address Kohasu, Oko-cho, Nankoku-shi, Kochi, Japan
Tel 088-880-2719
Email im62@kochi-u.ac.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 高知大学医学部

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 27 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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 04 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

Management information
Registered date
2019 Year 02 Month 11 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040822

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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