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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00782-45 | Other Identifier | ID RCB | |
| 14/25-941 | Other Identifier | CPP | |
| 140682B-82 | Other Identifier | ANSM |
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No participants enrolled
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| Name | Class |
|---|---|
| Institut de Recherche en Santé, Environnement et le Travail, France | OTHER |
| Laboratoire d'Etude des Résidus et Contaminants dans les Aliments | UNKNOWN |
| Institut national de l'environnement industriel et des risques |
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People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.
In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.
The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.
Pilot study for testing feasibility of cross sectional integrative exposure study.
Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).
Expected outcomes :
Assessment of feasibility to obtain:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure study | Other | 2-6 months-old children and 12-18 months-old children |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure study | Other | Sampling of blood, food, water, air and dust and delivery of dietary questionnaire |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility recruitment | Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures. Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol validation | Second objective is to validate protocols, procedures and methods to study exposure to PFAS. Secondary judgment criteria :
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Inclusion Criteria:
Young children (2-6 months ; 12-18 months)
Breastfeeding mother :
Exclusion Criteria:
Children :
For breastfeeding mother :
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Glorennec, PhD | Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail | Study Chair |
| Florence Rouget, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes Hospital University | Rennes | Brittany Region | 35033 | France |
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| National Agency for Sanitary Safety of the Food of the Environment and Labor | OTHER_GOV |
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| 1 year |