Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas - National Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 36
- 主要终点
- Impact of SDHi exposure in paraganglioma occurence
研究概览
简要总结
The primary objective of the PGL.EXPO-2 study is to test the hypothesis that exposure (occupational, environmental and/or domestic) to succinate dehydrogenase inhibitors (SDHi) could contribute to tumor emergence in subjects carrying a germline mutation in one of the SDHx genes.The primary endpoint will be the proportion of subjects (cases or controls) exposed to SDHi and the association with paraganglioma risk.
In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study
详细描述
Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to age and type of gene affected. Past exposures will be sought through a telephone questionnaire.
In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
- •Controls: SDHx mutation carriers with no SDHx-related tumor
排除标准
- •Incapacity to exercise free and informed consent for the study
- •Patient under tutorship or guardianship or legal safeguard
结局指标
主要结局
Impact of SDHi exposure in paraganglioma occurence
时间窗: 36 months
Association between exposures and tumor occurrence measure with Odd ratio
次要结局
- Spatial distribution of cases(48 months)
- Incidence rate in France of pathologies linked to SDHx gene mutations(48 months)