NCT01256606已完成不适用
Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy
Roche Sequencing Solutions6 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 6
- 主要终点
- Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
研究概览
简要总结
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is 18yrs or older
- •Subject has a singleton pregnancy
- •Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
- •Subject is able to provide consent
排除标准
- •Subject is pregnant with more than one fetus
- •Subject (mother) has known aneuploidy
- •Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
- •Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.
结局指标
主要结局
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
时间窗: 24 months
Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.
次要结局
未报告次要终点
研究者
研究点 (6)
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