Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,209
- 试验地点
- 8
- 主要终点
- Absence of chromosomal aneuploidy
研究概览
简要总结
The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.
详细描述
This is a prospective, multi-center specimen collection study; each subject's treatment, management, or medical care will not be determined by the study protocol.
Women 18 years of age or older with a viable pregnancy of at least 10 weeks gestation will be enrolled. A whole blood sample will be collected from each subject.
Subjects will be followed until data or specimens used to establish the clinical reference standard are collected, and pregnancy outcome and birth information is collected (if applicable). If cytogenetic test results from standard-of-care procedures are not available and pregnancies end in live births, a neonatal buccal swab specimen will be collected.
Maternal specimens will be processed to plasma and stored for future testing with an investigational NIPT(s). There will be no investigational NIPT results nor centralized CMA LDT results generated under this protocol.
Cytogenetic results from standard-of-care procedures and microarray results will be used to classify the clinical status of subjects according to the clinical reference standard.
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
- •Has a viable pregnancy of at least 10 weeks, 0 days gestation at the time of maternal specimen collection (singleton or multiple pregnancy acceptable),
- •Be 18 years of age or older at enrollment, and
- •Is willing and able to provide documentation of informed consent.
排除标准
- •Has a prior NIPT result from the current pregnancy,
- •Had an invasive prenatal diagnostic procedure (eg, CVS, amniocentesis) in the current pregnancy before maternal specimen collection,
- •Has a history of transplant or malignancy,
- •Had a transfusion of blood or blood components up to 8 weeks before maternal specimen collection,
- •Had preimplantation genetic screening for the current pregnancy (for in vitro fertilization patients only), or
- •Has already participated in the study (enrolled previously)
结局指标
主要结局
Absence of chromosomal aneuploidy
时间窗: 12 months
Collect up to 2,200 maternal blood samples with the number of affected samples with chromosomal aneuploidy less than 0.5% based on clinical data from standard of care invasive procedure, neonate physical exam or chromosomal microarray result from the neonate buccal swab specimen.
次要结局
未报告次要终点