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Completed

NCT Number: NCT06314633

Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children

PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de l'ouest

Saint-Herblain, 44800, France

About this study

Growing evidence points to a complex influence of the exposome on health outcomes. Epidemiological studies show associations between pesticides and cognitive delay and cancers. Only few were conducted in children. Chemical exposures differ between socioeconomic groups. The more disadvantaged the group, the higher are some exposures. However, the effect of the exposome on health is complicated to assess due to the long latencies of most diseases. It is therefore important to link social and chemical exposures to 'immediate' outcomes or molecular risk factors for human diseases. There is a strong connection between DNA damage and chronic diseases such as cancers. However, it is difficult to attribute these risks to specific impregnations.

The present study will address the impact of socioeconomic position, hence social inequalities, on environmental exposures and their biological consequences in children. Our approach is to detect DNA damage in hair follicles and associate these measurements with pesticide detections in the hair matrix and socioeconomic position (SEP).

PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children over 8 and under 12 years old at the time of inclusion
  • Children in school in class level CE2, CM1 or CM2
  • Living in the Pays de La Loire region, at least 80% of the time
  • Written informed assent and consent obtained from the participant and both parents or legal representative prior to performing any protocol-related procedures.

Exclusion criteria

  • Disorder precluding understanding of trial information or informed assent.

Treatment and study plan

Hair cut

Other

Hair locks and follicles will be cut twice in winter and spring

Socio-economic questionnaires

Other

Information about parents education levels and professional occupation, geographic area, children gender, indoor and outdoor children's environmental exposures

Primary outcomes

  1. Describe DNA damage

    Time frame: 4-6 months

    Hair locks and hair follicles will be collected and will be analysed to evaluate the DNA damage : average amount of DNA break foci per nucleus cross-section

  2. Describe DNA damage

    Time frame: 4-6 months

    Hair locks and hair follicles will be collected and will be analysed to evaluate the DNA damage: proportion of cells with an abnormal break rate.

  3. Describe socio-economic characteristics.

    Time frame: 4-6 months

    The socio-economic characteristics will evaluated via parent's questionnaires : parents occupation and education level

  4. Describe socio-economic characteristics.

    Time frame: 4-6 months

    The socio-economic characteristics will evaluated via parents questionnaires : parents education level

Secondary outcomes

  1. Characterize chemical exposome variations

    Time frame: 4-6 months

    Chemical exposome: presence and amount of pollutant impregnations : total number of polluants detected in hair sample

  2. Characterize chemical exposome variations

    Time frame: 4-6 months

    Chemical exposome: presence of pollutants/pesticides classified as genotoxic/carcinogenic by the WHO IARC (International Agency for Research on Cancer), and/or the US EPA (National Environmental Protection Agency).

  3. Characterize socio-economic indicators

    Time frame: 4-6 months

    The socio-economic characteristics will be evaluated via parents' questionnaires: parents' occupation and education level

  4. Characterize socio-economic indicators, geographical area, seasons

    Time frame: 4-6 months

    The socio-economic characteristics will be evaluated via parents' questionnaires: geographic area

  5. Characterize socio-economic indicators, geographical area, seasons

    Time frame: 4-6 months

    The socio-economic characteristics will be evaluated via parents' questionnaires: gender

  6. Characterize socio-economic indicators, geographical area, seasons

    Time frame: 4-6 months

    The socio-economic characteristics will be evaluated via parents' questionnaires: seasons (winter and spring)

  7. Describe DNA damage

    Time frame: 4-6 months

    Evaluate the DNA damage: average amount of DNA break foci per nucleus cross-section

  8. Describe DNA damage

    Time frame: 4-6 months

    Evaluate the DNA damage: proportion of cells with an abnormal break rate.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

  • ANSES

Registry information

Acronym: PESTIFOL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
May 22, 2026

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.