Clinical trial NCT02765529: Biomarkers of Exposure to Air Pollutants (AEROTOX-2)
Official title: Research of Biomarkers of Air Pollutants Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biomarkers of Air Pollution Exposure
Keywords: Environmental Pollution
Fine particles
Biomarkers
Elderly
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Universite du Littoral Cote d'Opale
First posted: 2016-05-06
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of expression of blood biomarkers of air pollution exposure
timeFrame: through the study completion, an average of 48 months
Secondary outcomes:
measure: Total amount of different populations of peripheral blood leucocytes
timeFrame: through the study completion, an average of 48 months
measure: Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)
timeFrame: through the study completion, an average of 48 months
measure: Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays
timeFrame: through the study completion, an average of 48 months
measure: Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts
timeFrame: through the study completion, an average of 48 months
measure: Detection of epigenetic modifications
timeFrame: through the study completion, an average of 48 months
measure: Correlation between age and markers of inflammation
timeFrame: through the study completion, an average of 48 months
measure: Correlation between age and markers of metabolic activity
timeFrame: through the study completion, an average of 48 months
measure: Correlation between age and markers genotoxicity
timeFrame: through the study completion, an average of 48 months
measure: Correlation between age and markers of epigenetic modifications
timeFrame: through the study completion, an average of 48 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Nutrition Center Naturalpha
state: Nord Pas-de-Calais
Study officials:
affiliation: Lille Catholic University
name: Gosset Pierre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCEIV
name: Sylvain Billet
role: STUDY_CHAIR
References: