UMIN-CTR Clinical Trial

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

Not specific

Classification by specialty

Obstetrics and Gynecology	Pediatrics	Adult
Child

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

The Ministry of the Environment, Gervenment of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

15

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

Registered date

2018

Year

01

Month

12

Day

Last modified on

2020

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035091