Automated Screen for Fetal Aneuploidy

Fluidic Automated Screening for Trisomy Study I

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03635359

Acronym

FAST1

Enrollment

2000

Registered

2018-08-17

Start date

2017-07-15

Completion date

2019-06-30

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trisomy 21 and Other Fetal Aneuploidy

Keywords

fetal, screening test, trisomy, aneuploidy, copy number variant

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.

Interventions

DIAGNOSTIC_TESTblood test

analysis of cell-free DNA in maternal plasma

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026