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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05158010
Other study ID # 2020-A03533-36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2021
Est. completion date June 25, 2022

Study information

Verified date June 2022
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of the life course, which will integrate data on the external, chemical, physical,behavioral, and social domains of the exposome, as well as on health outcomes and biological omics responses, from preconception until adolescence. As part of ATHLETE, the investigators will follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 25, 2022
Est. primary completion date June 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 18 Years
Eligibility Inclusion Criteria: For the adolescent : - Subject of the EDEN cohort included in the Helix cohort in 2014-2015 in Poitiers (16-19 years old) - Subject benefiting from a Social Security scheme or benefiting through a third party For the person legally responsible : - The legal guardian, if possible the mother, of the adolescent included in Athlete ; - Subject benefiting from a Social Security scheme or benefiting through a third person; - Free subject, without tutorship or guardianship or subordination. Exclusion Criteria: - Concomitant participation in another clinical research study. - Persons not benefiting from a Social Security scheme or not benefiting through a third party. - Adolescents who are incapable or who do not give their consent to follow the study procedures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HELIX's follow-up
Visit 1 (Day 0): clinical examination (anthropometry, bioimpedance, blood pressure,spirometry), neurodevelopment computer testing, questionnaires (Physical activity,diet, psychological distress, tobacco exposure, pubertal development, sleeping patterns, light exposure before going to sleep, outdoor environment (green spaces, noise), address history, home environment, socio-economic status, noise, psychological distress, medical history, medication use) 7 consecutive days (minimum) of personal exposure monitoring including wearing an actigraph, a Smartphone (GPS data), carrying a NO2 diffusion tube, collection of hair, stool, urines (2 urines during 6 consecutive days) and filling a sleep and physical activity diary Visit 2 (Day 8): blood collection early in the morning and collection of all the 7- days personal monitoring material, and stools and urines samples.

Locations

Country Name City State
France C.H.U. de Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary biomarkers exposure Measure of phtalates, phenols, pesticides, (organophosphorus pesticides, metabolites of pyrethroids, 2,4-dichlorophenoxyacid, boscalid, imazalil), cotinine, glycol ethers, polycyclic aromatic hydrocarbon, creatinine, exogenous metabolomics, in a weekly pool of urine collection One week
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