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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

March 1, 2012
May 6, 2013
January 2012
July 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01545674 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma Sample Prepared DNA
Non-Probability Sample

Pregnant Women
  • Trisomy 13
  • Trisomy 18
  • Trisomy 21
  • Aneuploidy
Procedure: Blood Draw
Blood will be drawn from the mother and father
Pregnant Women
Pregnant Women with elevated risk of trisomic pregnancy
Intervention: Procedure: Blood Draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact: Tasha Kalista 650-249-9090 ext 446 tkalista@natera.com
Contact: Ronald Wapner, MD 212-305-1521 rw2191@mail.cumc.columbia.edu
United States,   Canada,   Ireland,   Italy,   Korea, Republic of,   Spain
 
NCT01545674
GSN012B
Yes
Natera, Inc.
Natera, Inc.
  • Columbia University
  • George Washington University
  • National Institutes of Health (NIH)
Principal Investigator: Ronald Wapner, MD Columbia University
Natera, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP