Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 26
- 主要终点
- Collect samples and data for assay validation.
研究概览
简要总结
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
详细描述
To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •pregnant between 10 and 22 weeks gestation
- •18 years of age or older
- •provides signed and dated informed consent
- •subject is at increased risk for fetal aneuploidy
- •subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
- •subject agrees to provide the genetic results of the invasive procedure
排除标准
- •Fetal demise at time of specimen sampling
- •Previous sample donation under this protocol
结局指标
主要结局
Collect samples and data for assay validation.
时间窗: 9-24 weeks of gestatational age
Sensitivity and Specificity
次要结局
未报告次要终点
