UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035836 |
|---|---|
| Receipt number | 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 | 2024/02/19 23:59:53 |
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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
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
sumitama@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040822
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
