UMIN-CTR Clinical Trial

Basic information
Public title	Research to assess health disparities
Acronym	Research about health disparities
Scientific Title	Epidemic research to assess health disparities
Scientific Title:Acronym	Epidemic research about health disparities
Region	Japan

Condition
Condition	Healthy controls, allergic diseases, et cetera.
Classification by specialty	Medicine in general Pneumology Clinical immunology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess health disparities
Basic objectives2	Others
Basic objectives -Others	To assess health disparities in infancy and childhood
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Health disparities
Key secondary outcomes	The relationship between clinical factors and diseases including allergic diseases in infancy and childhood. The relationship between allergic rhinitis, asthma, and atopic dermatitis. The relationship between first milk and allergic diseases, etc.

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	16 years-old >
Gender	Male and Female
Key inclusion criteria	Children born in 2001 and 2010
Key exclusion criteria	Those who do not consent with this study.
Target sample size	80000

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Tabuchi
Organization	Osaka International Cancer Institute
Division name	Cancer Control Center
Zip code	541-8567
Address	1-69, Ohtemae 3-Chome, Chuo-ku, Osaka, 541-8567 Japan
TEL	+81-6-6945-1181
Email	tabuchitak@gmail.com

Public contact
Name of contact person	1st name Takahiro Middle name Last name Tabuchi
Organization	Osaka International Cancer Institute
Division name	Cancer Control Center
Zip code	541-8567
Address	1-69, Ohtemae 3-Chome, Chuo-ku, Osaka, 541-8567 Japan
TEL	+81-6-6945-1181
Homepage URL
Email	tabuchitak@gmail.com

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Ministry of education, culture, sports, science and technology
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	Osaka International Cancer Institute
Address	1-69, Ohtemae 3-Chome, Chuo-ku, Osaka, 541-8567 Japan
Tel	+81-6-6945-1181
Email	rinri01@opho.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	1508119060
Org. issuing International ID_1	Osaka International Cancer Institute
Study ID_2	1508119060-2
Org. issuing International ID_2	Osaka International Cancer Institute
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	85564
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	2000 Year 07 Month 15 Day
Date of IRB	2015 Year 01 Month 08 Day
Anticipated trial start date	2001 Year 01 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2020 Year 11 Month 13 Day
Last modified on	2020 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048427