Biomarkers of Exposure to Air Pollutants (AEROTOX-2) (AEROTOX-2)

April 15, 2026 updated by: Lille Catholic University

Research of Biomarkers of Air Pollutants Exposure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
        • Clinical Nutrition Center Naturalpha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: through the study completion, an average of 48 months
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)
Time Frame: through the study completion, an average of 48 months
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
Time Frame: through the study completion, an average of 48 months
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
Time Frame: through the study completion, an average of 48 months
through the study completion, an average of 48 months
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.
through the study completion, an average of 48 months
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.
through the study completion, an average of 48 months
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.
through the study completion, an average of 48 months
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.
through the study completion, an average of 48 months
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.
through the study completion, an average of 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Universite du Littoral Cote d'Opale

Investigators

  • Principal Investigator: Gosset Pierre, MD, Lille Catholic University
  • Study Chair: Sylvain Billet, UCEIV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimated)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-RT-13
  • 2015-A00983-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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