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Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)

This study is currently recruiting participants.
Verified May 2013 by Natera, Inc.
Sponsor:
Collaborators:
Columbia University
George Washington University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01545674
First received: March 1, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA in the maternal blood.


Condition Intervention
Trisomy 13
Trisomy 18
Trisomy 21
Aneuploidy
 Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Natera, Inc.:

Primary Outcome Measures:
  • Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y. [ Time Frame: Between first trimester screening (10-14 weeks GA) and invasive testing (amniocentesis or CVS). ] [ Designated as safety issue: No ]
    The primary objective is to determine the diagnostic capability of the test to detect autosomal aneuploidy (chromosomes 13, 18, 21) and sex aneuploidy (X and Y).


Biospecimen Retention:   Samples With DNA

Plasma Sample Prepared DNA


Estimated Enrollment: 1000
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant Women
Pregnant Women with elevated risk of trisomic pregnancy
 Procedure: Blood Draw
Blood will be drawn from the mother and father

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant Women

Criteria

Inclusion Criteria:

  1. Singleton pregnancy
  2. Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
  3. Mother has a high or moderate risk for trisomy
  4. Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure

Exclusion Criteria:

  1. Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
  2. Egg donor used
  3. Mother or father have known chromosomal abnormalities (including known balanced translocations)
  4. Participation in the study in a previous pregnancy
  5. Pregnancy is a result of IVF with pre-implantation genetic diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545674

Contacts
Contact: Tasha Kalista 650-249-9090 ext 446 tkalista@natera.com
Contact: Ronald Wapner, MD 212-305-1521 rw2191@mail.cumc.columbia.edu

  Show 31 Study Locations
Sponsors and Collaborators
Natera, Inc.
Columbia University
George Washington University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ronald Wapner, MD Columbia University
  More Information

Additional Information:
Press release announcing award of NIH grant to cover clinical trial  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT01545674     History of Changes
Other Study ID Numbers: GSN012B
Study First Received: March 1, 2012
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Natera, Inc.:
Aneuploidy
Non-invasive Prenatal Diagnosis
Prenatal Blood Test
Prenatal Aneuploidy Screening
Trisomy 13
Trisomy 18
 Trisomy 21
Trisomy
Down Syndrome
Turner Syndrome
Edwards Syndrome

Additional relevant MeSH terms:
Aneuploidy
Down Syndrome
Trisomy
Chromosome Aberrations
Pathologic Processes
Mental Retardation
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Chromosome Duplication

ClinicalTrials.gov processed this record on May 21, 2013