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临床试验/NCT07566780
NCT07566780尚未招募不适用

Prospective Collection of Maternal Venous Blood Samples for Cell-based Non- Invasive Prenatal Test Workflow

Menarini Silicon Biosystems0 个研究点目标入组 1,400 人开始时间: 2026年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,400

研究概览

简要总结

The aim of this study is to optimize a new non-invasive prenatal screening method based on the capture of fetal cells from maternal blood and to complete its development by obtaining maternal blood samples during the first trimester of pregnancy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Informed consent signed before any study-specific procedures
  • Pregnant women with singleton or twin pregnancy, at 8+0 - 14+6 week of gestation, aged ≥18 years
  • No medical contraindication for collecting 30 ml blood sample

排除标准

  • Unable to provide informed consent
  • Known infections that carry a risk of vertical transmission
  • Known maternal viral diseases: HIV and HCV, HBV

研究组 & 干预措施

Pregnant women

干预措施: Blood collection (Other)

研究者

发起方
Menarini Silicon Biosystems
申办方类型
Industry
责任方
Sponsor

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