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临床试验/NCT01451684
NCT01451684已完成不适用

Development of a Non-invasive Prenatal Test

Cindy Cisneros1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2011年6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
15,000
试验地点
1
主要终点
Absence of chromosomal abnormality

研究概览

简要总结

This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

详细描述

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

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

  • Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age
  • Subject is at least 10 weeks gestation for general enrollment
  • Subject has no known risk factors for chromosomal abnormalities of the fetus
  • Subject has no suspected or confirmed fetal abnormalities

排除标准

  • Subject is pregnant with more than two fetuses
  • Subject is unwilling to undergo a blood draw

结局指标

主要结局

Absence of chromosomal abnormality

时间窗: At time of enrollment

次要结局

未报告次要终点

研究者

发起方
Cindy Cisneros
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Cindy Cisneros

CRA

Roche Sequencing Solutions

研究点 (1)

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