- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635359
Automated Screen for Fetal Aneuploidy (FAST1)
August 14, 2018 updated by: BioCeryx
Fluidic Automated Screening for Trisomy Study I
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sydney, Australia
- Royal Prince Alfred Hospital
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Brussels, Belgium
- University Hospital Brugmann
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Vancouver, Canada
- University of British Columbia
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Lisbon, Portugal
- Hospital Cuf Descobertas
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Murcia, Spain
- Hospital Clinico Universitario Virgen de la Arrixaca
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London, United Kingdom
- University College London Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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positive for fetal aneuploidy
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analysis of cell-free DNA in maternal plasma
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negative for fetal aneuploidy
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analysis of cell-free DNA in maternal plasma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Comparison of blood test to fetal karyotype
Time Frame: 21 months
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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.
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21 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas J Musci, MD, BioCeryx
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 15, 2017
Primary Completion (ANTICIPATED)
March 31, 2019
Study Completion (ANTICIPATED)
June 30, 2019
Study Registration Dates
First Submitted
August 14, 2018
First Submitted That Met QC Criteria
August 14, 2018
First Posted (ACTUAL)
August 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCX 120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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