Biomarkers of Exposure to Air Pollutants (AEROTOX-2)

NCT ID: NCT02765529

Last Updated: 2017-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

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.

Conditions

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Biomarkers of Air Pollution Exposure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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20-30 years

Blood sampling

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

45-55 years

Blood sampling

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

70-80 years

Blood sampling

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Control

Blood sampling for standardization of technical procedures

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Interventions

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Blood sampling

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universite du Littoral Cote d'Opale

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gosset Pierre, MD

Role: PRINCIPAL_INVESTIGATOR

Lille Catholic University

Sylvain Billet

Role: STUDY_CHAIR

UCEIV

Locations

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Clinical Nutrition Center Naturalpha

Lille, Hauts-de-France, France

Site Status

Countries

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France

Other Identifiers

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2015-A00983-46

Identifier Type: OTHER

Identifier Source: secondary_id

2015-RT-13

Identifier Type: -

Identifier Source: org_study_id

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