Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Natera, Inc.
- 入组人数
- 136
- 试验地点
- 32
- 主要终点
- The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.
研究概览
简要总结
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin
排除标准
- •Monozygotic twin pregnancy
- •Non twin pregnancy
- •Maternal history of bone marrow or organ transplantation
结局指标
主要结局
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.
时间窗: 2 Years
Each complete participant in the study will have multiple maternal blood samples collected, and a child buccal swab. This outcome will use genetic analysis to reflect for each participant if the algorithm correctly or incorrectly identified the LT versus the DT. Accuracy, defined as the number of VT pairs correctly identified as the LT and DT, divided by the total number of VT pairs, will be calculated.
Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT.
时间窗: 2 years
A new algorithm will be written to analyze the serial research blood samples to return a fetal fraction of each twin, and identify which twin is the DT verses the LT. The fetal fraction measurement will be a percentage, and it will be measurable, or not measurable for each sample.
次要结局
- The accuracy of the updated algorithm for the assignment of risk for trisomy 21/18/13 for the LT in DZ twins with a single LT.(3 Years)