1. Japan Environment and Children’s Study (Jecs)

2. Jecs Longitudinal birth cohort study enrolling 100,000 pregnant women and following up their children until they reach 13 years of age Study protocol involving provider/community based recruitment, biological sample collection, questionnaire administration, medical examination and environmental exposure assessment The goal is to better understand the impact of environmental exposures on children’s health and development and to improve their health and future environment Environment includes indoor and outdoor air, water, soil and dust, diet, noise, socio-economic status, education, occupation, mental and social support Genetic factors will also be examined 2

3. Jecs organisation 3

4. Jecs study locations 4

5. Jecs road map and budget 2009201020112012201320142015FY…2032 FY: Fiscal year starting April, * Funding not provided by JECS Pilot Study Main Study Main Study Recruitment Substudy Biological sample analysis Adjunct Studies* Case-cohort/case-control b yen 7 6 5 4 3 2 1 0 ca. m USD 87.5 75 62.5 50 37.5 25 12.5 0 5

6. Jecs study design Multi-layered prospective birth cohort study Main Study involves 100,000 mother–child pairs (+ fathers when accessible) from 15 Study Locations Following the participants until children become 13 years of age Pilot Study evaluates the feasibility, acceptability and cost of the proposed outcome and exposure measurement procedures as well as Study administration protocols to be used in the Main Study Sub-study: A sub-cohort (n = 5,000) will be formed within Main Study to examine extended exposure–outcome relationships Indoor exposure vs. medical examination Case–cohort and nested case–control studies for rare diseases Adjunct Studies are conducted on a portion of the Main Study cohort, of which protocols are reviewed and approved by the Steering Committee Jecs is a flexible and developing study, learning from other studies 6

7. Jecs priority outcomes OutcomesExamples Pregnancy/reproductionStillbirth, preterm delivery, low birth weight Congenital anomaliesCleft lip and palate, ventricular septal defect, hypospadias, cryptorchidism, Down syndrome Neurodevelopmental disordersAutism spectrum disorders, learning disability, ADHD Immunological disordersAsthma, atopic dermatitis, food allergy, Kawasaki disease Metabolic disordersGlucose metabolism disorder, obesity CancersLeukaemia, solid cancers 7

8. Jecs exposure metrics Exposure metricsExamples BiomonitoringBlood, breast milk: POPs, metals, allergens Urine: Cotinine, pesticides, PPCPs, phthalates, PFCs, phenols Hair: Hg Environmental monitoringIndoor air: VOCs, aldehydes, PM2.5 House dust: POPs, pesticides, PFCs, PPCPs, metals, allergens ModellingAtmosphere: Vehicle exhaust, NO 2, O 3, PM2.5, PAHs Exposure modelling: air, water, soil, dust, diet, noise, ionising radiation QuestionnaireFood frequency, chemical use, product use, SES, housing conditions 8

9. Mechanism-oriented epidemiology Exposure 1 Exposure 2 Exposure 3 ⋮ Exposure k ⋮ Exposure n−2 Exposure n−1 Exposure n Exposure 1 Exposure 2 Exposure 3 ⋮ Exposure k ⋮ Exposure n−2 Exposure n−1 Exposure n Biomarker 1 Biomarker 2 Biomarker 3 ⋮ Biomarker k ⋮ Biomarker n−2 Biomarker n−1 Biomarker n Biomarker 1 Biomarker 2 Biomarker 3 ⋮ Biomarker k ⋮ Biomarker n−2 Biomarker n−1 Biomarker n Outcome 1 Outcome 2 Outcome 3 ⋮ Outcome k ⋮ Outcome n−2 Outcome n−1 Outcome n Outcome 1 Outcome 2 Outcome 3 ⋮ Outcome k ⋮ Outcome n−2 Outcome n−1 Outcome n ExposomeBiomarkers Genome Transcriptomics/proteomics/ metabolomics/epigenetics... 9

10. International harmonisation World Health Organisation (WHO) Japan Environment and Children’s Study (Jecs), Japan Shanghai Birth Cohort Study, Shanghai, China Germany, planning longitudinal birth cohort study French Longitudinal Study of Children (Elfe), France National Children’s Study (NCS), US Sample collection – Timing and frequency, volume, container, location, technique Storage – Transport, condition, container, period Analysis – Method performance, QA/QC measures, reference material sharing Data handling – Missing data, non-detects, outliers, units/normalisation 10

11. Acknowledgement Participating families Jecs Regional Centre staffs Jecs National Centre staffs International Working Group Members Taxpayers For more information: http://www.env.go.jp/en/chemi/hs/jecs jecscore@nies.go.jp 11