NCT03635359UnknownNot Applicable
Fluidic Automated Screening for Trisomy Study I
BioCeryx6 sites in 6 countries2,000 target enrollmentStarted: July 15, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Locations
- 6
- Primary Endpoint
- Comparison of blood test to fetal karyotype
Study Overview
Brief Summary
The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is at least 18 years old and can provide informed consent;
- •Subject has a viable singleton or twin pregnancy;
- •Subject is confirmed to be at least 10 weeks, 0 days gestation at the time of the study blood draw;
- •Subject is planning to undergo chorionic villus sampling and/or amniocentesis for the purpose of genetic analysis of the fetus because of a suspected fetal chromosomal anomaly based on cell-free DNA test results, standard serum screening result, or fetal ultrasound abnormality.
- •OR the subject has already undergone chorionic villus sampling and/or amniocentesis and is known to have a fetus with a chromosomal abnormality confirmed by genetic analysis.
Exclusion Criteria
- •Subject (the mother) has known aneuploidy;
- •Subject is pregnant with more than two fetuses or has had sonographic evidence of three or more gestational sacs at any time during pregnancy;
- •Subject has a fetal demise (including natural or elective reduction) identified prior to consent;
- •Subject has history of malignancy treated with chemotherapy and/or major surgery, or bone marrow transplant.
Outcomes
Primary Outcomes
Comparison of blood test to fetal karyotype
Time Frame: 21 months
Maternal plasma cell-free DNA will be analyzed to determine copy number of specific chromosomes and compared to the fetal karyotype as obtained through invasive diagnostic testing of the fetus.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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