NCT00770458已完成不适用
Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 7
- 主要终点
- Compare investigational assay results for Down Syndrome to standard of care results.
研究概览
简要总结
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female
- •Subject is pregnant
- •Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
- •Subject is willing to provide blood specimen
排除标准
- •Subject is not pregnant
- •Subject is not willing to provide blood specimen
- •Subject is not haveing aneuploid screening
结局指标
主要结局
Compare investigational assay results for Down Syndrome to standard of care results.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (7)
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