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Automated Screen for Fetal Aneuploidy (FAST1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635359
Recruitment Status : Unknown
Verified August 2018 by BioCeryx.
Recruitment status was:  Enrolling by invitation
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborators:
Brugmann University Hospital
University of British Columbia
Royal Prince Alfred Hospital, Sydney, Australia
Hospital Universitario Virgen de la Arrixaca
Hospital CUF Descobertas, Lisbon, Portugal
University College London Hospitals
Information provided by (Responsible Party):
BioCeryx

Study Description
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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.

Condition or disease Intervention/treatment
Trisomy 21 and Other Fetal Aneuploidy Diagnostic Test: blood test

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fluidic Automated Screening for Trisomy Study I
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
positive for fetal aneuploidy Diagnostic Test: blood test
analysis of cell-free DNA in maternal plasma
negative for fetal aneuploidy Diagnostic Test: blood test
analysis of cell-free DNA in maternal plasma


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635359


Locations
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Australia
Royal Prince Alfred Hospital
Sydney, Australia
Belgium
University Hospital Brugmann
Brussels, Belgium
Canada
University of British Columbia
Vancouver, Canada
Portugal
Hospital CUF Descobertas
Lisbon, Portugal
Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
United Kingdom
University College London Hospital
London, United Kingdom
Sponsors and Collaborators
BioCeryx
Brugmann University Hospital
University of British Columbia
Royal Prince Alfred Hospital, Sydney, Australia
Hospital Universitario Virgen de la Arrixaca
Hospital CUF Descobertas, Lisbon, Portugal
University College London Hospitals
Investigators
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Principal Investigator: Thomas J Musci, MD BioCeryx
More Information
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Responsible Party: BioCeryx
ClinicalTrials.gov Identifier: NCT03635359    
Other Study ID Numbers: BCX 120
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioCeryx:
fetal
screening test
trisomy
aneuploidy
copy number variant
Additional relevant MeSH terms:
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Down Syndrome
Aneuploidy
Trisomy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn