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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Children
• Intervention / Treatment: Other: Hair cut; Other: Socio-economic questionnaires

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44800
    • Institut de Cancérologie de l'Ouest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: study procedures; Hair cut for DNA damage and chemical exposome variation analysis and Socio-economic characteristics	Other: Hair cut; Hair locks and follicles will be cut twice in winter and spring; Other: Socio-economic questionnaires; Information about parents education levels and professional occupation, geographic area, children gender, indoor and outdoor children's environmental exposures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe DNA damage	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	4-6 months
Describe DNA damage	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.	4-6 months
Describe socio-economic characteristics.	The socio-economic characteristics will evaluated via parent's questionnaires : parents occupation and education level	4-6 months
Describe socio-economic characteristics.	The socio-economic characteristics will evaluated via parents questionnaires : parents education level	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize chemical exposome variations	Chemical exposome: presence and amount of pollutant impregnations : total number of polluants detected in hair sample	4-6 months
Characterize chemical exposome variations	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).	4-6 months
Characterize socio-economic indicators	The socio-economic characteristics will be evaluated via parents' questionnaires: parents' occupation and education level	4-6 months
Characterize socio-economic indicators, geographical area, seasons	The socio-economic characteristics will be evaluated via parents' questionnaires: geographic area	4-6 months
Characterize socio-economic indicators, geographical area, seasons	The socio-economic characteristics will be evaluated via parents' questionnaires: gender	4-6 months
Characterize socio-economic indicators, geographical area, seasons	The socio-economic characteristics will be evaluated via parents' questionnaires: seasons (winter and spring)	4-6 months
Describe DNA damage	Evaluate the DNA damage: average amount of DNA break foci per nucleus cross-section	4-6 months
Describe DNA damage	Evaluate the DNA damage: proportion of cells with an abnormal break rate.	4-6 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: ANSES

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: DNA damage; Chemical exposome; Hair polluants impregnations; Socio-economic characteristics
• Other Study ID Numbers: ICO-2023-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No