Research of Biomarkers of Air Pollutants Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Level of expression of blood biomarkers of air pollution exposure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
20-30 years
Blood sampling
干预措施: Blood sampling (Procedure)
45-55 years
Blood sampling
干预措施: Blood sampling (Procedure)
70-80 years
Blood sampling
干预措施: Blood sampling (Procedure)
Control
Blood sampling for standardization of technical procedures
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Level of expression of blood biomarkers of air pollution exposure
时间窗: 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.
次要结局
- Correlation between age and markers of metabolic activity(through the study completion, an average of 48 months)
- Total amount of different populations of peripheral blood leucocytes(through the study completion, an average of 48 months)
- Measure of the expression of genes involved in metabolism by quantitative polymerase chain reaction (qPCR)(through the study completion, an average of 48 months)
- Measure of the expression of genes involved in metabolism by TaqMan Gene Expression Assays(through the study completion, an average of 48 months)
- Detection of epigenetic modifications(through the study completion, an average of 48 months)
- Detection of genotoxicity by identification of DNA double-strand breaks and DNA adducts(through the study completion, an average of 48 months)
- Correlation between age and markers genotoxicity(through the study completion, an average of 48 months)
- Correlation between age and markers of inflammation(through the study completion, an average of 48 months)
- Correlation between age and markers of epigenetic modifications(through the study completion, an average of 48 months)