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临床试验/NCT02923440
NCT02923440招募中不适用

Creation of a French South-Eastern Database and DNA-bank of Congenital Heart Disease to Explore the Genetic Pathways

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
number of patient with Congenital Heart Defects

研究概览

简要总结

Congenital heart defects are seen in 0,8% of life births. In France this means more than 5000 newborns per year. The south-east region of France is particularly affected as a result of a higher birth rate and consanguinity, when compared to other regions. The majority of congenital heart diseases remain unexplained. Genetic causes are indisputable but remain poorly understood. Genetic research needs the availability of a large-scale DNA collection, guided by a robust phenotypic classification. Such a DNA-bank has been created in Paris (CARREG DNA bank, created by the M3C reference centre for congenital heart diseases). Such a bank is currently unavailable in south-east France. To transport biological specimens from Marseille to Paris would be very expensive. In addition, the whole infrastructure required for correct diagnosis and classification of the congenital heart diseases, for sampling, for storage of the samples and genetic analysis, does exist in our AP-HM hospital and in our AMU research unit. For those reasons it is highly preferable to elaborate such a database and DNA-bank locally. The acronym SEA-HD (South-EAst-Heart-Diseases) would be used to name this DNA-bank

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Echocardiographic diagnosis of congenital heart defect falling within the classification Houyel and Bonnet
  • Necessity of making a blood test regardless of study
  • Medical care in the AP-HM Timone Hospital children, medical-surgical unit of pediatric and congenital cardiology, Marseille - These Parent Child

排除标准

  • Pregnant women
  • Patients or parent / legal guardian (if minor) in physical or mental incapacity to understand or sign the consent
  • People in Emergencies
  • Persons deprived of freedom
  • Persons not beneficiaries of a social security scheme
  • Persons in health or social institution

结局指标

主要结局

number of patient with Congenital Heart Defects

时间窗: 3years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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