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Completed

NCT Number: NCT05158010

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

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).

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Key information

Conditions

Exposure Behavior Environment Health Behavior

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.H.U. de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Urinary biomarkers exposure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: ATHLETE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2021
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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