ATHLETE: Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05158010

Collaborator

(none)

Enrollment

Location

Arm

7.5

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Exposure Health Behavior Environment	Other: HELIX's follow-up	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

Actual Study Start Date :

Nov 10, 2021

Actual Primary Completion Date :

Jun 25, 2022

Actual Study Completion Date :

Jun 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: HELIX's follow-up	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.

Arm

Intervention/Treatment

Other: HELIX's follow-up

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.

Outcome Measures

Primary Outcome Measures

Urinary biomarkers exposure [One week]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C.H.U. de Poitiers	Poitiers		France	86000

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT05158010

Other Study ID Numbers:

2020-A03533-36

First Posted:

Dec 15, 2021

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 1, 2022