NCT02201862已完成不适用
Non-Invasive Chromosomal Evaluation of Trisomy Study
Cindy Cisneros3 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2014年4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
- 2,000
- 试验地点
- 3
- 主要终点
- Detection of aneuploidy
研究概览
简要总结
This study is being conducted to provide clinically annotated samples to support continued improvements in the Ariosa Test content, methodology, specimen processing and quality control.
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 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 CVS and/or amniocentesis for the purpose of genetic analysis of the fetus OR the subject has already undergone CVS and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
排除标准
- •Subject 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
Detection of aneuploidy
时间窗: 24 months
次要结局
未报告次要终点
研究者
Cindy Cisneros
CRA
Roche Sequencing Solutions
研究点 (3)
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