Biomarkers of Air Pollution ExposureAEROTOX-2NCT02765529
Biomarkers of Exposure to Air Pollutants (AEROTOX-2)
A study testing Blood sampling in people with Biomarkers of Air Pollution Exposure, run by Lille Catholic University at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers of Air Pollution Exposure
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Clinical Nutrition Center Naturalpha
Lille, Hauts-de-France, 59000
About this study
Official title: 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.
Read the 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.
- Conditions
- Biomarkers of Air Pollution Exposure
- Being tested
- Blood sampling
- Keywords
- Environmental Pollution, Fine particles, Biomarkers, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 20-30 years | Experimental | Blood sampling Receives: Procedure: Blood sampling |
| 45-55 years | Experimental | Blood sampling Receives: Procedure: Blood sampling |
| 70-80 years | Experimental | Blood sampling Receives: Procedure: Blood sampling |
| Control | Experimental | Blood sampling for standardization of technical procedures Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of expression of blood biomarkers of air pollution exposure
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.
Measured: through the study completion, an average of 48 months
Secondary outcomes (9)
Total amount of different populations of peripheral blood leucocytes
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts
Measured: through the study completion, an average of 48 months
Detection of epigenetic modifications
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.
Measured: through the study completion, an average of 48 months
Correlation between age and markers of inflammation
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Correlation between age and markers of metabolic activity
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Correlation between age and markers genotoxicity
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Correlation between age and markers of epigenetic modifications
After exposure of leukocytes to doses of fine particles.
Measured: through the study completion, an average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biomarkers of Air Pollution ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Universite du Littoral Cote d'Opale
- Responsible party
- Sponsor
- Investigators
- Gosset Pierre, MD, Principal investigator, Lille Catholic UniversitySylvain Billet, Study chair, UCEIV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765529
- Sponsor's protocol ID
- 2015-RT-13
- Other IDs
- 2015-A00983-46
- Acronym
- AEROTOX-2
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2016
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fougere B, Landkocz Y, Lepers C, Martin PJ, Armand L, Grossin N, Verdin A, Boulanger E, Gosset P, Sichel F, Shirali P, Billet S. Influence of aging in the modulation of epigenetic biomarkers of carcinogenesis after exposure to air pollution. Exp Gerontol. 2018 Sep;110:125-132. doi: 10.1016/j.exger.2018.05.018. Epub 2018 May 31.
PubMed 29860068
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of Biomarkers of Air Pollutants Exposure
- ClinicalTrials.gov ID
- NCT02765529
- Acronym / sponsor ID
- AEROTOX-2 / 2015-RT-13
- Conditions
- Biomarkers of Air Pollution Exposure
- Keywords
- Environmental Pollution, Fine particles, Biomarkers, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Universite du Littoral Cote d'Opale
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20-30 years | Experimental | Procedure: Blood samplingBlood sampling |
| 45-55 years | Experimental | Procedure: Blood samplingBlood sampling |
| 70-80 years | Experimental | Procedure: Blood samplingBlood sampling |
| Control | Experimental | Procedure: Blood samplingBlood sampling for standardization of technical procedures |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling | Procedure or surgery | 20-30 years, 45-55 years, 70-80 years, Control |
Primary outcome
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.
9 secondary outcomes
Total amount of different populations of peripheral blood leucocytes
Time frame: 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
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
Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts
Time frame: through the study completion, an average of 48 months
Detection of epigenetic modifications
Time frame: 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
Correlation between age and markers of metabolic activity
Time frame: 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
Correlation between age and markers of epigenetic modifications
Time frame: through the study completion, an average of 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 29860068Fougere B, Landkocz Y, Lepers C, Martin PJ, Armand L, Grossin N, Verdin A, Boulanger E, Gosset P, Sichel F, Shirali P, Billet S. Influence of aging in the modulation of epigenetic biomarkers of carcinogenesis after exposure to air pollution. Exp Gerontol. 2018 Sep;110:125-132. doi: 10.1016/j.exger.2018.05.018. Epub 2018 May 31.
- Individual participant dataSharing planned: No
Related trials for Biomarkers of Air Pollution Exposure
RecruitingObservational study
Tumors and Respiratory System Diseases Due to Air Pollution: New Biomarkers of Exposure and Effects
COPD, Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gosset Pierre, MD principal investigator
Lille Catholic University
Sylvain Billet study chair
UCEIV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Biomarkers of Air Pollution Exposure, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of expression of blood biomarkers of air pollution exposure (time frame: through the study completion, an average of 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.