Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests
研究概览
简要总结
This study will assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13. The results obtained from Vanadis NIPT will be compared with the study site's current prenatal screening methods. The primary objectives are: 1) To assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in the maternal healthcare setting, 2) To assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests, and 3) To evaluate preliminary cost effectiveness of Vanadis NIPT use in different models. The secondary objective is to assess the feasibility of Vanadis NIPT regarding determination of fetal sex.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •between the age of 18 and 55 years (inclusive)
- •≥ 10+0 weeks gestation
排除标准
- •Pregnant woman undergoing amniocentesis without any screening test result
- •Pregnant woman with previous severe hypotension episodes or other conditions that may complicate the blood sampling
- •Known maternal aneuploidy
- •Known maternal cancer
- •Invasive test (chorionic villus sampling or amniocentesis) performed before blood sampling for NIPT
结局指标
主要结局
Assess preliminary performance of Vanadis NIPT for screening of T21 in comparison to site's routine screening methods i.e. combined and integrated tests
时间窗: Three weeks
次要结局
- Assess the feasibility of Vanadis NIPT for screening of T21, T18 and T13 in comparison to fetal karyotype from invasive testing, and by evaluating overall usability of the test in routine laboratory work.(Three weeks)
- Evaluate preliminary cost effectiveness of Vanadis NIPT by evaluating resources, false positive rates and detection rates(Three weeks)
- Assess feasibility of Vanadis NIPT regarding determination of fetal sex by comparing the Vanadis NIPT result with the fetal karyotype from invasive testing(Three weeks)