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Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

Research of Biomarkers of Air Pollutants Exposure

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02765529
Acronym
AEROTOX-2
Enrollment
101
Registered
2016-05-06
Start date
2015-11-01
Completion date
2016-12-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers of Air Pollution Exposure

Keywords

Environmental Pollution, Fine particles, Biomarkers, Elderly

Brief summary

Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been reported in part due to the rising in life expectancy. For instance, exposure to air pollution, and in particularly to fine particles has been classified by the International Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly population particularly sensitive. However, no validated biomarkers have been identified to assess the exposure to fine particles maybe correlated to cancerogenesis. AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses of fine particles. Secondly, the study aims to analyze, according to age, the leukocytes response to the urban pollution exposure.

Detailed description

To estimate the influence of the atmospheric pollution on the whole adult population, subjects will be recruited in a wide range of age (20 - 80 years). Samples of atmospheric particles will be collected in Dunkerque (North of France), one of the most important industrial areas in France. This city is influenced by car traffic, urban and industrial activities, and the wide sea traffic of the North Sea. Therefore, Dunkerque is a reference site to study the atmospheric pollution and its impact on health. These markers will be searched in association with the different mechanisms involved in the toxicity of the fine particles such as: inflammatory response, genotoxicity, metabolic activity and epigenetic changes after exposure of leukocytes isolated from patients to doses of fine particles. The study of the correlation between biological observations and conditions of exposure to air particles will bring answers about the impact of the environmental pollution on the health of vulnerable populations.

Interventions

PROCEDUREBlood sampling

Sponsors

Lille Catholic University
Lead SponsorOTHER
Universite du Littoral Cote d'Opale
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Age between 20-30 years, 45-55 years or 70-80 years * Signature of an informed consent * Non-smoker or ex-smoker for more than 10 years * Homogeneous repartition between men and women * Social insurance affiliation * Understanding or being able to speak French

Exclusion criteria

* Pregnant or breast feeding woman * Treatment with parenteral corticoids in the 30 days prior to inclusion visit, treatment with immunosuppressant drugs, radiotherapy, chemotherapy * Occupational exposure (metallurgy, petrochemistry, house painter) for more than 10 years and having ceased all activities in these areas for less than 10 years ago.

Design outcomes

Primary

MeasureTime frameDescription
Level of expression of blood biomarkers of air pollution exposurethrough the study completion, an average of 48 monthsThese markers will be searched in association with the different mechanisms involved in the toxicity of the fine particles such as: inflammatory response, genotoxicity, metabolic activity and epigenetic changes after exposure of leukocytes to doses of fine particles.

Secondary

MeasureTime frameDescription
Total amount of different populations of peripheral blood leucocytesthrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)through the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assaysthrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Detection of genotoxicity by identification of DNA double-strand breaks and DNA adductsthrough the study completion, an average of 48 months
Detection of epigenetic modificationsthrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles. In order to measure the expression of hundreds of miRNAs within a given sample a microarray analysis technology will be performed using the TaqMan® Low Density Array Human MicroRNA.
Correlation between age and markers of inflammationthrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Correlation between age and markers of metabolic activitythrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Correlation between age and markers genotoxicitythrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.
Correlation between age and markers of epigenetic modificationsthrough the study completion, an average of 48 monthsAfter exposure of leukocytes to doses of fine particles.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGosset Pierre, MD

Lille Catholic University

STUDY_CHAIRSylvain Billet

UCEIV

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026