Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02210299
Status:
WITHDRAWN
Last Update Posted:
2015-06-10
First Post:
2014-08-05
Brief Title:
TEXTO Total EXposure To Organic Pollutants
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
TEXTO Total EXposure To Organic Pollutants
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEXTO
Brief Summary:
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 childrens 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
In this context the objective of this project is to characterize the young childrens 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
Detailed Description:
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
original data on childrens body burden
original contamination data for food water air and dust
Matching of these data to identify main sources and pathways of exposure
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
original data on childrens body burden
original contamination data for food water air and dust
Matching of these data to identify main sources and pathways of exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 140682B-82 | OTHER | ANSM | None |
| 2014-A00782-45 | OTHER | None | None |
| 1425-941 | OTHER | None | None |