Clinical trial NCT06314633: Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children
Official title: Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteer Children
Keywords: DNA damage
Chemical exposome
Hair polluants impregnations
Socio-economic characteristics
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: ANSES
First posted: 2024-03-18
Enrollment: 140
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hair collection and parents questionnaires
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Describe DNA damage
timeFrame: 4-6 months
measure: Describe DNA damage
timeFrame: 4-6 months
measure: Describe socio-economic characteristics.
timeFrame: 4-6 months
measure: Describe socio-economic characteristics.
timeFrame: 4-6 months
Secondary outcomes:
measure: Characterize chemical exposome variations
timeFrame: 4-6 months
measure: Characterize chemical exposome variations
timeFrame: 4-6 months
measure: Characterize socio-economic indicators
timeFrame: 4-6 months
measure: Characterize socio-economic indicators, geographical area, seasons
timeFrame: 4-6 months
measure: Characterize socio-economic indicators, geographical area, seasons
timeFrame: 4-6 months
measure: Characterize socio-economic indicators, geographical area, seasons
timeFrame: 4-6 months
measure: Describe DNA damage
timeFrame: 4-6 months
measure: Describe DNA damage
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'ouest
Study officials:
References: