PregnancyCARENCT01663350
Comparison of Aneuploidy Risk Evaluations
An observational study of Pregnancy and Down Syndrome, run by Verinata Health, Inc. at 26 sites in United States.
Trial summary
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Down Syndrome, Edwards Syndrome
- How many people
- 3,000 participants
- Where
- 26 sitesUnited States
- Study dates
- Jul 2012to Jul 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.
Who may be able to join
- Age 18 years or older at enrollment
- Clinically confirmed pregnancy
- Gestational age ≥8 weeks, 0 days
- Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester)
- Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)
- Able to provide consent for participation using language appropriate forms
Who cannot join
- Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
- Prenatal screening determination by Nuchal Translucency (NT) measurement only
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Network Office of Research and Innovation Lehigh Valley Health Network
Allentown, Pennsylvania
AD Williams Laboratory
Atlanta, Georgia
Medical University of South Carolina
Charleston, South Carolina
Prentice Women's Hospital
Chicago, Illinois
Maternal Fetal Medicine
Cleveland, Ohio
South Carolina Clinical Research
Columbia, South Carolina
Practice Research Organization
Dallas, Texas
Greenville Hospital Systems
Greenville, South Carolina
Jackson Clinic
Jackson, Tennessee
Desert Perinatal Associates
Las Vegas, Nevada
Northshore University Hospital
Manhasset, New York
MacDonald Clinical Research Unit
Mayfield Heights, Ohio
Winthrop University Hospital
Mineola, New York
University of Minnesota
Minneapolis, Minnesota
St. Peter's University Hospital
New Brunswick, New Jersey
Long Island Jewish Medical Center
New Hyde Park, New York
Mount Sinai Medical Center
New York, New York
Eastern Virginia Medical School
Norfolk, Virginia
The Group for Women
Norfolk, Virginia
Lyndhurst Clinical Research
Raleigh, North Carolina
William Beaumont Hospital
Royal Oak, Michigan
West Coast OB/GYN
San Diego, California
Washington University
St Louis, Missouri
Jacobi Medical Center
The Bronx, New York
Virtua Perinatology Associates of Voorhees
Voorhees Township, New Jersey
Lyndhurst Clinical Research
Winston-Salem, North Carolina
About this study
Official title: Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.
- Conditions
- Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome, Turners Syndrome
- Medical subject headings
- Down Syndrome, Trisomy 18 Syndrome, Trisomy 13 Syndrome, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All-risk pregnant women | All-risk pregnancies undergoing conventional forms of prenatal screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verinata Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy J Sehnert, MD, Study director, Verinata Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663350
- Sponsor's protocol ID
- VER-0007
- Acronym
- CARE
- Status last verified
- Jul 2013
- First submitted
- 31 Jul 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
PubMed 24571752
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an 'All-Risk' Population
- ClinicalTrials.gov ID
- NCT01663350
- Acronym / sponsor ID
- CARE / VER-0007
- Conditions
- Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome, Turners Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Verinata Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- First posted
- 13 Aug 2012 (estimated)
- 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.
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in 'all-risk' pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All-risk pregnant women | – | –All-risk pregnancies undergoing conventional forms of prenatal screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of pregnant women at least 18 years of age, who meet the study eligibility criteria. Women who plan or have already completed prenatal screening for fetal aneuploidy during first and/or second trimester, will be recruited from approved participating clinical centers.
Key inclusion criteria (6 listed)
- Age 18 years or older at enrollment
- Clinically confirmed pregnancy
- Gestational age ≥8 weeks, 0 days
- Planned or completed prenatal serum screening* (drawn during 1st and/or 2nd trimester)
- Pregnancy records accessible and available for data collection (e.g., results from screening, ultrasound examinations, invasive prenatal procedures if performed, and newborn hospital discharge exam)
Key exclusion criteria (2 listed)
- Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
- Prenatal screening determination by Nuchal Translucency (NT) measurement only
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care).
Time frame: 12 months
The primary outcome of this study is the false positive rate of fetal aneuploidy detection for chromosome 21, 18, and 13 by the Verinata Health Prenatal Aneuploidy Test and screen positive rate for fetal trisomy (T21) and trisomy (T18) by conventional prenatal screening methods. Birth outcomes, or karyotype if available, will be used as the reference standard.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Derived from this study: PubMed 24571752Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
Related trials for Pregnancy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
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.
Amy J Sehnert, MD study director
Verinata Health, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Down Syndrome, run by Verinata Health, Inc. at 26 sites in United States.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 screen positive rates between investigational testing results and conventional screening results (standard of care). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01663350, which also lists 1 linked publication.
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 16 Jul 2013.