Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of fetal cells recovered and quality of DNA data on each cell
研究概览
简要总结
The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for healthy pregnant subjects:
- •18 years or older
- •65 or younger
排除标准
- •for healthy pregnant subjects:
- •Acute illness
- •Unavailability of maternal blood sample of at least 30 ml
- •Language barrier (non-English speaking )
- •Maternal age of less than 18 years, or over 65
- •Higher order multiple pregnancy (triplet or greater)
结局指标
主要结局
Number of fetal cells recovered and quality of DNA data on each cell
时间窗: 3 years
Outcome 1 is the number of cells identified as fetal by microscopic staining. This can be converted to units based on volume. If 40 mL of blood is collected and f8 cells are designated as fetal based on microscopic staining, the results can be tabulated as follow: So a result is 8 cells are identified as fetal from one blood draw. This equals 0.2 cells identified per mL of maternal blood. If two or fewer cells are obtained, a blood redraw will be requested from the patient.
次要结局
未报告次要终点