A Multicentric Case-control Study to Assess the Association Between Environmental, Domestic and Occupational Exposures During Antenatal and Early Postnatal Periods and the Risk to Develop a Testicular Germ Cell Tumor During Adulthood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,367
- 试验地点
- 22
- 主要终点
- Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood
研究概览
简要总结
The incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in France in 30 years. Reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. Reliable data on environmental exposure during this critical period are sparse.The discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability.
We conduct a multicentric case-control study to assess this association. Cases and controls will be enrolled during a 18-month period. They will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances.
An optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls.
Mothers (or close relative) of cases and controls will also be contacted (with son's agreement). If they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances.
Cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.
详细描述
Environmental exposure to pesticides will be assessed from subject's residential history, using a Geographic Information System.
Occupational exposure to pesticides and other nuisances will be assessed by an industrial hygienist who will be in charge to encode all subjects and mothers' occupations.
Domestic exposure to pesticides will be assessed from type, target and frequency of domestic pesticide use.
Based on these 3 sources of exposure, a score of exposition will be calculated for each case and each control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 18 and 44 years old
- •Born in metropolitan France
- •Able to understand, read and write French
- •Without any psychiatric and severe cognitive disorder
- •Willingness to participate to the study
- •Who has signed and dated an inform consent form
- •Affiliated to a health care system
排除标准
- •Who has a legal guardian
- •History of testicular germ cell tumor or cryptorchidism (only for controls)
结局指标
主要结局
Assess the association between pesticide exposure during Antenatal and Early Postnatal Periods and the risk of testicular cancer during adulthood
时间窗: at the end of enrollment (18 months)
Occupational, environmental and domestic exposures to pesticides and other nuisances will be assessed.
次要结局
- Assess the association between a combined exposure to pesticides and the risk of testicular cancer during adulthood(at the end of enrollment (18 months))
- Analyse polymorphisms known to be associated with testicular cancer risk to explore gene-environment interactions(one year after the end of enrollment)