EXPOSO-METER - Characterizing the Environmental and Human Exposome of Mixtures of Pollutants at High Trophic Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patterns of the human exposome in three global regions
研究概览
简要总结
Motivation of this study
Human life is full of chemicals: They support the provision of cure, clothes, shelter, transportation and even nourishment of the world population. But can they also represent a risk for humans? Many of these chemicals can be taken up into the human body. Often, they are transformed and excreted directly, but some chemicals persist over longer time periods or accumulate in living organisms. Since there are many thousands of chemicals in the environment and products humans use on a daily basis, there may be complex mixtures around, and consequently also in the human body. The investigators start a new project at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. It is called EXPOSO-METER and attempts to make these chemicals measurable in an easy and comparable way, to better characterize this potential hazard. With the valuable contribution of the participants and collaborators, the investigators will be able to describe and compare the situation for similar groups of study participants in Central Europe, North America and Asia. The aim is to characterize the chemicals and see which potential effects their presence may have. In the project, the investigators will also compare human samples to material from the environment, e.g., seal and fox samples, to improve the understanding of the occurrence and fate of chemicals in the environment and in the human body.
详细描述
Determination of sample size
The research project EXPOSO-METER does not aim for a large cohort study but for a proof-of-concept pilot study that will form the basis for future work. Therefore, two approaches were followed to determine the sample size:
- Based on a literature review of similar studies, a closely matching example from a high-level journal was identified. It worked with 16 individuals in total from two German cities (different tissues, in total 88 samples). The work in EXPOSO-METER will by far exceed this number of study participants. Furthermore, three global regions are expected to show explicit large-scale differences due to distinct lifestyle and exposure conditions in the U.S., Europe and South Korea.
- Cochran's formula [n= (Z^2 p(1-p))/e^2] was applied for sample size calculation: with a 90 percent confidence level (Z=1.645), maximum variability (50 percent, i.e., p=0.5) and +/-10 percent precision (e=0.1), it renders a minimum sample size of 68 participants.
As a combined result, the minimum sample size is therefore 50 study participants per region, with 100 study participants being ideal per region.
Sample collection
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •willingness to contribute to the EXPOSO-METER research
- •cover geographical patterns
- •cover all sexes and age groups to derive patterns
排除标准
- 未提供
结局指标
主要结局
Patterns of the human exposome in three global regions
时间窗: samples will be collected only on the very same day when the planned surgery is carried out, questionnaires will be filled in the same context
A wide range of chemicals will be determined in the human tissue and blood samples. In total, 150 + 400 chemicals are analyzed by gas/liquid chromatography (GC/LC) coupled to high-resolution mass spectrometry (HRMS) or tandem mass spectrometry (MS/MS) following the sample treatment described above. The resulting data will be used to describe and compare the patterns across geographical scales, and correlations of the observed chemical patterns with different characteristics of the study participants (such as age, sex, height, weight, and certain lifestyle factors (e.g. smoking status, nutritional aspects) etc.) will be investigated.
次要结局
未报告次要终点