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

NCT ID: NCT06314633

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteer Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Hair collection and parents questionnaires
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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study procedures

Hair cut for DNA damage and chemical exposome variation analysis and Socio-economic characteristics

Group Type OTHER

Hair cut

Intervention Type OTHER

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

Socio-economic questionnaires

Intervention Type OTHER

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

Interventions

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Hair cut

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

Intervention Type OTHER

Socio-economic questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ANSES

OTHER

Sponsor Role collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancérologie de l'ouest

Saint-Herblain, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie ROBERT, MD

Role: CONTACT

+33240679900

Nadia ALLAM, PHD

Role: CONTACT

+33240679826

Facility Contacts

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Marie ROBERT, MD

Role: primary

Pierre VIDI, PhD

Role: backup

Other Identifiers

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ICO-2023-13

Identifier Type: -

Identifier Source: org_study_id

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