A Safer Pre-Natal Diagnosis Using Free DNA in Maternal Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,632
- 试验地点
- 1
- 主要终点
- Validation of method of novel analysis for Aneuploidy
研究概览
简要总结
A diagnostic peripheral maternal blood test taken and the free foetal DNA is analysed and the presence of trisomies using a novel method.
详细描述
A total of ~2000 participants have donated blood samples used for the development and validation of the IONA non-invasive prenatal screening test for Downs, Edwards and Patau syndrome. The IONA Test was CE marked Feb 2013. We are now recruiting a further 800 participants to provide blood samples to further develop and verify the test for other chromosomal abnormalities and to improve test efficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient/subject is willing and able to give informed consent for participation in the study.
- •Female, aged 16 years or above.
- •Currently pregnant at time of entry to the study.
- •Pregnancy having been identified as 'high-risk' by screening test.
排除标准
- •The patient/subject may not enter the study if ANY of the following apply:
- •The participant herself has Down's Syndrome or other chromosomal abnormality.
- •Children under 16
- •Adults with learning disabilities
- •Adults who are unconscious or very severely ill
- •Adults who have a terminal illness
- •Adults in emergency situations
- •Adults suffering from a mental illness
- •Adults with dementia
- •Prisoners
- •Young offenders
- •Adults who are unable to consent for themselves
- •Any person considered to have a particularly dependent relationship with investigators
结局指标
主要结局
Validation of method of novel analysis for Aneuploidy
时间窗: 2013 Approx
Analysis of maternal blood by a selective amplification of fetal DNA over maternal DNA within that sample. Patients to be followed up for 1 year.
次要结局
- Optimization of existing methods for maximising ffDNA(up to July 2019)