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

NCT06314633 | Recruiting

• 1 other identifier: ICO-2023-13
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy Volunteer Children

Keywords

DNA damage; Chemical exposome; Hair polluants impregnations; Socio-economic characteristics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Characterize chemical exposome variations

  4-6 months

• Characterize chemical exposome variations

  4-6 months

• Characterize socio-economic indicators

  4-6 months

• Characterize socio-economic indicators, geographical area, seasons

  4-6 months

• Characterize socio-economic indicators, geographical area, seasons

  4-6 months

Study Arms (1)

study procedures

OTHER

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

Other: Hair cut; Other: Socio-economic questionnaires

Interventions

Hair cut OTHER

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

study procedures

Socio-economic questionnaires OTHER

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

study procedures

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- Disorder precluding understanding of trial information or informed assent.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• ANSES: collaborator

Study Sites (1)

Institut de Cancérologie de l'ouest

Saint-Herblain, 44800, France

RECRUITING

Central Study Contacts

Marie ROBERT, MD

CONTACT

+33240679900; Marie.Robert@ico.unicancer.fr

Nadia ALLAM, PHD

CONTACT

+33240679826; nadia.allam@ico.unicancer.fr

Study Design

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

Model Details: Hair collection and parents questionnaires

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: January 29, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

FR (1)