Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

Lille Catholic University

Status: Completed

Conditions: Biomarkers of Air Pollution Exposure

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02765529

2015-A00983-46 (Other Identifier)

2015-RT-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 4 patient groups

20-30 years

Experimental group

Description:

Blood sampling

Treatment:

Procedure: Blood sampling

45-55 years

Experimental group

Description:

Blood sampling

Treatment:

Procedure: Blood sampling

70-80 years

Experimental group

Description:

Blood sampling

Treatment:

Procedure: Blood sampling

Control

Experimental group

Description:

Blood sampling for standardization of technical procedures

Treatment:

Procedure: Blood sampling