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临床试验/NCT01429389
NCT01429389招募中不适用

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

Sequenom, Inc.26 个研究点 分布在 2 个国家目标入组 2,000 人开始时间: 2011年5月1日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (26)

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