NCT01451671已完成不适用
Prenatal Test for Fetal Aneuploidy Detection
Cindy Cisneros3 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2010年11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
- 1,500
- 试验地点
- 3
- 主要终点
- Identification of aneuploidy
研究概览
简要总结
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.
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
- 否
入选标准
- •Subject has singleton pregnancy
- •Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
- •Subject is able to provide informed consent
- •Subject is ≥ 18 years of age
排除标准
- •Subject is pregnant with more than one fetus
- •Subject (mother) has a known aneuploidy
结局指标
主要结局
Identification of aneuploidy
时间窗: At enrollment
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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