Comparison of Aneuploidy Risk Evaluations (CARE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Verinata Health, Inc.
ClinicalTrials.gov Identifier:
NCT01663350
First received: July 31, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition
Pregnancy
Down Syndrome
Edwards Syndrome
Patau Syndrome
Turners Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Verinata Health, Inc.:

Primary Outcome Measures:
  • Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Plasma


Estimated Enrollment: 3000
Study Start Date: July 2012
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
All-risk pregnant women
All-risk pregnancies undergoing conventional forms of prenatal screening

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment
  • Prenatal screening determination by Nuchal Translucency (NT) measurement only
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663350

  Show 26 Study Locations
Sponsors and Collaborators
Verinata Health, Inc.
Investigators
Study Director: Amy J Sehnert, MD Verinata Health, Inc.
  More Information

No publications provided by Verinata Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Verinata Health, Inc.
ClinicalTrials.gov Identifier: NCT01663350     History of Changes
Other Study ID Numbers: VER-0007
Study First Received: July 31, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneuploidy
Down Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Trisomy
Chromosome Disorders
Chromosome Aberrations
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Chromosome Duplication

ClinicalTrials.gov processed this record on September 15, 2014