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临床试验/NCT04481152
NCT04481152已完成不适用

Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Feasability of the protocol of a national case/control study (PGL.EXPO2)

研究概览

简要总结

The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers

详细描述

The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers.

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 sex, age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

结局指标

主要结局

Feasability of the protocol of a national case/control study (PGL.EXPO2)

时间窗: 2 years

Successful pairing of 50 cases with 50 controls

次要结局

  • Ease of matching cases and controls(2 years)
  • Feasibility of matching cases and controls(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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