NCT03635359Unknown不适用
Fluidic Automated Screening for Trisomy Study I
BioCeryx6 个研究点 分布在 6 个国家目标入组 2,000 人开始时间: 2017年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Comparison of blood test to fetal karyotype
研究概览
简要总结
The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18 years old and can provide informed consent;
- •Subject has a viable singleton or twin pregnancy;
- •Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
- •Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.
- •OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
排除标准
- •Subject (the mother) has known aneuploidy;
- •Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
- •Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
- •Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.
结局指标
主要结局
Comparison of blood test to fetal karyotype
时间窗: 21 months
Maternal plasma cell-free DNA will be analyzed to determine copy number of specific chromosomes and compared to the fetal karyotype as obtained through invasive diagnostic testing of the fetus.
次要结局
未报告次要终点
研究者
研究点 (6)
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