NCT01122524已完成不适用
A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 11
- 主要终点
- Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
研究概览
简要总结
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).
Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.
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
- •Age 18 years or older
- •Clinically confirmed viable pregnancy at the time of enrollment
- •Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
- •Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
- •Able to provide consent for participation using language appropriate forms and consent process
排除标准
- •Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment
结局指标
主要结局
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
时间窗: 10 months
次要结局
未报告次要终点
研究者
研究点 (11)
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