NL-OMON48766已完成不适用
Fluidic Automated Screening for Trisomy-Study I (FAST Study I) - FAST-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects meeting all of the following criteria will be considered eligible for
- •enrollment in the study.
- •1. Subject is at least 18 years old and can provide informed consent;
- •2. Subject has a viable singleton or twin pregnancy;
- •3. Subject is confirmed to be at least 10 weeks, 0 days gestation at the time
- •of the study blood draw;
- •4. Subject is planning to undergo CVS and/or amniocentesis for the purpose of
- •genetic analysis of the fetus because of a suspected fetal chromosomal anomaly
- •based on cfDNA test results, standard serum screening result, or fetal
- •ultrasound abnormality.
- •5. OR the subject has already undergone CVS and/or amniocentesis and is known
- •to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •1. Subject (the mother) has known aneuploidy or copy number variant (CNV);
- •2. Subject is pregnant with more than two fetuses or has had sonographic
- •evidence of three or more gestational sacs at any time during pregnancy;
- •3. Subject has a fetal demise (including natural or elective reduction)
- •identified prior to consent;
- •4. Subject has history of malignancy treated with chemotherapy and/or major
- •surgery, or bone marrow transplant;
研究者
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