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

NCT05158010 | Completed

• 1 other identifier: 2020-A03533-36
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Exposure; Health Behavior; Environment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HELIX's follow-up

OTHER

Other: HELIX's follow-up

Interventions

HELIX's follow-up OTHER

* 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.

HELIX's follow-up

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U. de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: December 15, 2021
• Study Start: November 10, 2021
• Primary Completion: June 25, 2022
• Study Completion: June 25, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

FR (1)