NCT01052688已完成不适用
Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- NIPD result compared to standard test results
研究概览
简要总结
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female
- •Subject is 18 years or older
- •Subject is no less than 8 and no more than 36 weeks gestation
- •Subject provides a signed and dated informed consent
- •Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
- •Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)
排除标准
- •Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy
结局指标
主要结局
NIPD result compared to standard test results
时间窗: baseline
Result of NIPD test will be compared to the standard test results obtained by karyotype, FISH, QF-PCR, and/or commerical NIPD result.
次要结局
未报告次要终点
研究者
研究点 (10)
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