Biomarkers of Air Pollution Exposure Clinical Trial
— AEROTOX-2Official title:
Research of Biomarkers of Air Pollutants Exposure
| Verified date | January 2017 |
| Source | Lille Catholic University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Clinical Nutrition Center Naturalpha | Lille | Nord Pas-de-Calais |
| Lead Sponsor | Collaborator |
|---|---|
| Lille Catholic University | Université du Littoral Côte d’Opale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | through the study completion, an average of 48 months | No |
| Secondary | Total amount of different populations of peripheral blood leucocytes | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR) | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts | through the study completion, an average of 48 months | No | |
| Secondary | 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. | through the study completion, an average of 48 months | No |
| Secondary | Correlation between age and markers of inflammation | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Correlation between age and markers of metabolic activity | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Correlation between age and markers genotoxicity | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |
| Secondary | Correlation between age and markers of epigenetic modifications | After exposure of leukocytes to doses of fine particles. | through the study completion, an average of 48 months | No |