Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Research of Biomarkers of Air Pollutants Exposure

Conditions
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Biomarkers of Air Pollution Exposure

Intervention / Treatment
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* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20-30 years<br>Blood sampling | Procedure: Blood sampling<br> <br> |
| Experimental: 45-55 years<br>Blood sampling | Procedure: Blood sampling<br> <br> |
| Experimental: 70-80 years<br>Blood sampling | Procedure: Blood sampling<br> <br> |
| Experimental: Control<br>Blood sampling for standardization of technical procedures | Procedure: Blood sampling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of expression of blood biomarkers of air pollution exposure | 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 to doses of fine particles. | through the study completion, an average of 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of different populations of peripheral blood leucocytes | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR) | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts |  | through the study completion, an average of 48 months | 
| Detection of epigenetic modifications | After 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. | through the study completion, an average of 48 months | 
| Correlation between age and markers of inflammation | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Correlation between age and markers of metabolic activity | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Correlation between age and markers genotoxicity | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 
| Correlation between age and markers of epigenetic modifications | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environmental Pollution, Fine particles, Biomarkers, Elderly