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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030786
Receipt No. R000035091
Scientific Title The Japan Environment and Children's Study
Date of disclosure of the study information 2018/01/15
Last modified on 2020/03/25

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Basic information
Public title The Japan Environment and Children's Study
Acronym JECS
Scientific Title The Japan Environment and Children's Study
Scientific Title:Acronym JECS
Region
Japan

Condition
Condition Not specific
Classification by specialty
Obsterics and gynecology Pediatrics Adult
Child
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate environmental impact on children's health and development
Basic objectives2 Others
Basic objectives -Others To evaluate the effects of exposure to chemical substances during the foetal stage and/or in early childhood on children's health and development
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Five priority outcomes: 1) reproduction and pregnancy
complications, 2) congenital
anomalies, 3) neuropsychiatric disorders, 4) allergies and immune system deficiencies,
5) metabolism and endocrine system disorders.
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 (1) A pregnant woman whose expected delivery date must be between 1 August 2011 and 31 March 2014
(2) A pregnant woman must reside in one of the study areas selected by Regional Centres at the time of the recruitment and be expected to reside continually in Japan for the fore-seeable future
(3) A pregnant woman must visit a cooperating health care providers selected by a Regional Centre or local government offices to obtain a Mother-Child Health Handbook in a study area during the recruiting period
Key exclusion criteria (1) A pregnant woman does not consent to participate in the study
(2) A pregnant woman shows difficulty in comprehending the study procedures or filling out the questionnaires without support
(3) A pregnant woman is reportedly not accessible at the time of delivery (e.g. a woman who plans to give birth outside the study area)
Target sample size 100000

Research contact person
Name of lead principal investigator
1st name Michihiro
Middle name
Last name Kamijima
Organization Nagoya City University
Division name Graduate School of Medical Sciences
Zip code 467-8601
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8171
Email kamijima@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Shin
Middle name
Last name Yamazaki
Organization National Institute for Environmental Studies
Division name JECS Programme Office
Zip code 305-8506
Address 16-2 Onogawa, Tsukuba, Ibaraki, Japan
TEL 029-850-2226
Homepage URL http://www.env.go.jp/chemi/ceh/index.html
Email yamazaki.shin@nies.go.jp

Sponsor
Institute National Institute for Environmental Studies, JECS Programme Office
National Center for Child Health and Development, JECS Medical Support Center
Institute
Department

Funding Source
Organization The Ministry of the Environment, Gervenment of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Hokkaido University
Sapporo Medical University
Asahikawa Medical University
The Japanese Red Cross, Hokkaido College of Nursing
Tohoku University
Fukushima Medical University
Chiba University
Yokohama City University
University of Yamanashi
Shinshu University
University of Toyama
Nagoya City University
Kyoto University
Doshisha University
Osaka University
Osaka Women's and Children's Hospital
Hyogo College of Medicine
Tottori University
Kochi University
University of Occupational and Environmental Health
Kyushu University
Kumamoto University
University of Miyazaki
University of the Ryukyu
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, National Institute for Environmental Studies
Address 16-2 Onogawa, Tsukuba, Ibaraki, Japan
Tel 029-850-2226
Email yamazaki.shin@nies.go.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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 15 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 103095
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
2010 Year 08 Month 09 Day
Date of IRB
2010 Year 08 Month 09 Day
Anticipated trial start date
2011 Year 01 Month 24 Day
Last follow-up date
2033 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A series of questionnaires are used to measure covariates and potential confounders including demographic variables (e.g. residential address, education, employment, house-hold income), lifestyle factors (e.g. stress level, diet, smoking and drinking habits, exercise, sleep), physical environment (e.g., heat, ionizing radiation, housing condition, and neighbourhood), social/psychological factors (e.g., personality, social support), medical history (including pregnancy history) and medical history of family members.

Management information
Registered date
2018 Year 01 Month 12 Day
Last modified on
2020 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035091

Research Plan
Registered date File name
2019/07/25 研究計画書(第1.61版)(20181015).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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