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Completed

NCT Number: NCT02765529

Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

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.

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Key information

Conditions

Biomarkers of Air Pollution Exposure

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Center Naturalpha

Lille, Hauts-de-France, 59000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sampling

Procedure

Primary outcomes

  1. Level of expression of blood biomarkers of air pollution exposure

    Time frame: through the study completion, an average of 48 months

    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.

Secondary outcomes

  1. Total amount of different populations of peripheral blood leucocytes

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  2. Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  3. Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  4. Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts

    Time frame: through the study completion, an average of 48 months

  5. Detection of epigenetic modifications

    Time frame: through the study completion, an average of 48 months

    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.

  6. Correlation between age and markers of inflammation

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  7. Correlation between age and markers of metabolic activity

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  8. Correlation between age and markers genotoxicity

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

  9. Correlation between age and markers of epigenetic modifications

    Time frame: through the study completion, an average of 48 months

    After exposure of leukocytes to doses of fine particles.

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Universite du Littoral Cote d'Opale

Registry information

Official study title

Research of Biomarkers of Air Pollutants Exposure

Acronym: AEROTOX-2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.