Trisomy 21 and Other Fetal AneuploidyFAST1NCT03635359
Automated Screen for Fetal Aneuploidy
An observational study of Trisomy 21 and Other Fetal Aneuploidy, run by BioCeryx at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trisomy 21 and Other Fetal Aneuploidy
- What is being tested?
- blood test
- How many people
- 2,000 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 15 Jul 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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.
- Conditions
- Trisomy 21 and Other Fetal Aneuploidy
- Being tested
- blood test
- Keywords
- fetal, screening test, trisomy, aneuploidy, copy number variant
- Medical subject headings
- Down Syndrome, Trisomy, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
analysis of cell-free DNA in maternal plasma
| Study group | Role | What they receive |
|---|---|---|
| positive for fetal aneuploidy | Not described Receives: Diagnostic Test: blood test | |
| negative for fetal aneuploidy | Not described Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Jul 2017
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trisomy 21 and Other Fetal AneuploidyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCeryx
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Sponsor
- Investigators
- Thomas J Musci, MD, Principal investigator, BioCeryx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635359
- Sponsor's protocol ID
- BCX 120
- Acronym
- FAST1
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluidic Automated Screening for Trisomy Study I
- ClinicalTrials.gov ID
- NCT03635359
- Acronym / sponsor ID
- FAST1 / BCX 120
- Conditions
- Trisomy 21 and Other Fetal Aneuploidy
- Keywords
- fetal, screening test, trisomy, aneuploidy, copy number variant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- BioCeryxIndustry (pharma, biotech, devices)
- 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
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive for fetal aneuploidy | – | Diagnostic Test: blood test |
| negative for fetal aneuploidy | – | Diagnostic Test: blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant with singleton or twin pregnancy and having and indicated physician prescribed prenatal diagnostic procedure.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testanalysis of cell-free DNA in maternal plasma | Diagnostic test | negative for fetal aneuploidy, positive for fetal aneuploidy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Musci, MD principal investigator
BioCeryx
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trisomy 21 and Other Fetal Aneuploidy, run by BioCeryx at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Belgium, Canada, Portugal, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of blood test to fetal karyotype (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.