Automated Screen for Fetal Aneuploidy

• Conditions: Trisomy 21 and Other Fetal Aneuploidy
• Interventions: Diagnostic Test: blood test

• Registration Number: NCT03635359
• Lead Sponsor: BioCeryx

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-15
• Status Verified: 2018-08
• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17
• Primary Completion: 2019-03-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

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 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.
5. 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

1. Subject (the mother) has known aneuploidy;
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
positive for fetal aneuploidy	blood test	-
negative for fetal aneuploidy	blood test	-

Primary Outcome Measures

Name	Time	Method
Comparison of blood test to fetal karyotype	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.

Trial Locations

Locations (6)

University Hospital Brugmann; 🇧🇪 Brussels, Belgium

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Royal Prince Alfred Hospital; 🇦🇺 Sydney, Australia

University of British Columbia; 🇨🇦 Vancouver, Canada

Hospital CUF Descobertas; 🇵🇹 Lisbon, Portugal

University College London Hospital; 🇬🇧 London, United Kingdom