Automated Screen for Fetal Aneuploidy

Trisomy 21 and Other Fetal Aneuploidy Clinical Trial

— FAST1  

Official title:

Fluidic Automated Screening for Trisomy Study I

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03635359
• Other study ID #: BCX 120
• Status: Enrolling by invitation
• Start date: July 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: BioCeryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: June 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Trisomy 21 and Other Fetal Aneuploidy

Intervention

Diagnostic Test:
• blood test
analysis of cell-free DNA in maternal plasma

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney
Belgium	University Hospital Brugmann	Brussels
Canada	University of British Columbia	Vancouver
Portugal	Hospital CUF Descobertas	Lisbon
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
United Kingdom	University College London Hospital	London

Sponsors (7)

Lead Sponsor	Collaborator
BioCeryx	Brugmann University Hospital, Hospital CUF Descobertas, Lisbon, Portugal, Hospital Universitario Virgen de la Arrixaca, Royal Prince Alfred Hospital, Sydney, Australia, University College London Hospitals, University of British Columbia

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of blood test to fetal karyotype	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.	21 months