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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Columbia University
George Washington University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01545674
First received: March 1, 2012
Last updated: September 20, 2016
Last verified: September 2016

March 1, 2012
September 20, 2016
January 2012
April 2014   (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.
First trimester screening is the current standard of care for pregnant women in the United States. Women with a high screening risk for trisomy then have invasive testing, which carries a risk of miscarriage, to definitively determine if the fetus has trisomy. Because of the high false negative rate of the first trimester screening, an unacceptable number of trisomic fetuses are not detected. Moreover, because of the high false positive rate, an unacceptable number of women undergo invasive follow up testing. Additional screening tests are needed that combine a high sensitivity, a low false positive rate, and minimal or no risk to the fetus.
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 Blood Draw
Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw
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.
 
Active, not recruiting
1000
December 2016
April 2014   (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
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Ireland,   Italy,   Korea, Republic of,   Spain
 
NCT01545674
GSN012B, 1R44HD062114
Yes
No
A peer reviewed publication is planned from this study.
Natera, Inc.
Natera, Inc.
  • Columbia University
  • George Washington University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Ronald Wapner, MD Columbia University
Natera, Inc.
September 2016

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