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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03635359




Registration number
NCT03635359
Ethics application status
Date submitted
14/08/2018
Date registered
17/08/2018
Date last updated
17/08/2018

Titles & IDs
Public title
Automated Screen for Fetal Aneuploidy
Scientific title
Fluidic Automated Screening for Trisomy Study I
Secondary ID [1] 0 0
BCX 120
Universal Trial Number (UTN)
Trial acronym
FAST1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trisomy 21 and Other Fetal Aneuploidy 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - blood test

positive for fetal aneuploidy -

negative for fetal aneuploidy -


Diagnosis / Prognosis: blood test
analysis of cell-free DNA in maternal plasma

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
21 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Canada
State/province [2] 0 0
Vancouver
Country [3] 0 0
Portugal
State/province [3] 0 0
Lisbon
Country [4] 0 0
Spain
State/province [4] 0 0
Murcia
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioCeryx
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Brugmann University Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of British Columbia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Hospital Universitario Virgen de la Arrixaca
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Hospital CUF Descobertas, Lisbon, Portugal
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University College London Hospitals
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03635359
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas J Musci, MD
Address 0 0
BioCeryx
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03635359