NCT05671744招募中不适用
Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
Menarini Biomarkers Singapore1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Fetal chromosomal abnormalities detection in circulating fetal cells,
研究概览
简要总结
The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Participant has a viable singleton or twin pregnancy
- •Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
- •Participant is at least 18 years old and can provide informed consent
排除标准
- •Unable to provide informed consent
- •Prenatal diagnosis of clinical Chorioamnionitis
- •Intake of drugs or exposure to teratogenic agents
- •Infections that carry a risk of vertical transmission
- •Known maternal viral diseases: HIV and HCV, HBV
结局指标
主要结局
Fetal chromosomal abnormalities detection in circulating fetal cells,
时间窗: 2 year
Evaluation of clinical performance of a cell-based technology for fetal chromosomal abnormalities detection in circulating fetal cells, using maternal blood samples from a population of high-risk pregnancies undergoing clinically indicated fetal diagnostic procedures.
次要结局
- Number of suitable fetal cells(2 year)
- Fetal sex assessment(2 year)
研究者
研究点 (1)
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