Healthy Volunteer ChildrenPESTIFOLNCT06314633
Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children
A study testing Hair cut and Socio-economic questionnaires in people with Healthy Volunteer Children, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Children
- What is being tested?
- Hair cut and Socio-economic questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Disorder precluding understanding of trial information or informed assent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteer Children
- Being tested
- Hair cut, Socio-economic questionnaires
- Keywords
- DNA damage, Chemical exposome, Hair polluants impregnations, Socio-economic characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair cutOther
Hair locks and follicles will be cut twice in winter and spring
Socio-economic questionnairesOther
Information about parents education levels and professional occupation, geographic area, children gender, indoor and outdoor children's environmental exposures
| Study group | Role | What they receive |
|---|---|---|
| study procedures | Other | Hair cut for DNA damage and chemical exposome variation analysis and Socio-economic characteristics Receives: Other: Hair cut; Other: Socio-economic questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4-6 months
Describe socio-economic characteristics.
The socio-economic characteristics will evaluated via parent's questionnaires : parents occupation and education level
Measured: 4-6 months
Describe socio-economic characteristics.
The socio-economic characteristics will evaluated via parents questionnaires : parents education level
Measured: 4-6 months
Secondary outcomes (8)
Characterize chemical exposome variations
Chemical exposome: presence and amount of pollutant impregnations : total number of polluants detected in hair sample
Measured: 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).
Measured: 4-6 months
Characterize socio-economic indicators
The socio-economic characteristics will be evaluated via parents' questionnaires: parents' occupation and education level
Measured: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
The socio-economic characteristics will be evaluated via parents' questionnaires: geographic area
Measured: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
The socio-economic characteristics will be evaluated via parents' questionnaires: gender
Measured: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
The socio-economic characteristics will be evaluated via parents' questionnaires: seasons (winter and spring)
Measured: 4-6 months
Describe DNA damage
Evaluate the DNA damage: average amount of DNA break foci per nucleus cross-section
Measured: 4-6 months
Describe DNA damage
Evaluate the DNA damage: proportion of cells with an abnormal break rate.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start29 Jan 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Hair collection and parents questionnaires
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- ANSES
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314633
- Sponsor's protocol ID
- ICO-2023-13
- Acronym
- PESTIFOL
- Status last verified
- May 2026
- First submitted
- 11 Mar 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children
- ClinicalTrials.gov ID
- NCT06314633
- Acronym / sponsor ID
- PESTIFOL / ICO-2023-13
- Conditions
- Healthy Volunteer Children
- Keywords
- DNA damage, Chemical exposome, Hair polluants impregnations, Socio-economic characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- ANSES
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hair collection and parents questionnaires
| Arm | Type | Receives |
|---|---|---|
| study procedures | Other | Other: Hair cut, Other: Socio-economic questionnairesHair cut for DNA damage and chemical exposome variation analysis and Socio-economic characteristics |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Disorder precluding understanding of trial information or informed assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair cutHair locks and follicles will be cut twice in winter and spring | Other | study procedures |
| Socio-economic questionnairesInformation about parents education levels and professional occupation, geographic area, children gender, indoor and outdoor children's environmental exposures | Other | study procedures |
Primary outcome
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
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.
Describe socio-economic characteristics.
Time frame: 4-6 months
The socio-economic characteristics will evaluated via parent's questionnaires : parents occupation and education level
Describe socio-economic characteristics.
Time frame: 4-6 months
The socio-economic characteristics will evaluated via parents questionnaires : parents education level
8 secondary outcomes
Characterize chemical exposome variations
Time frame: 4-6 months
Characterize chemical exposome variations
Time frame: 4-6 months
Characterize socio-economic indicators
Time frame: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
Time frame: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
Time frame: 4-6 months
Characterize socio-economic indicators, geographical area, seasons
Time frame: 4-6 months
Describe DNA damage
Time frame: 4-6 months
Describe DNA damage
Time frame: 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair cut and Socio-economic questionnaires in people with Healthy Volunteer Children, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe DNA damage (time frame: 4-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.