Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)
This study is ongoing, but not recruiting participants.
Sponsor:
Natera, Inc.
Collaborators:
Columbia University
George Washington University
Information provided by (Responsible Party):
Natera, Inc.
ClinicalTrials.gov Identifier:
NCT01545674
First received: March 1, 2012
Last updated: October 28, 2014
Last verified: October 2014
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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:
Genetics Home Reference related topics:
Down syndrome
tetrasomy 18p
trisomy 13
trisomy 18
Turner syndrome
MedlinePlus related topics:
Down Syndrome
Genetic and Rare Diseases Information Center resources:
Chromosomal Triplication
Gonadal Dysgenesis
Turner Syndrome
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: | December 2015 |
| Primary Completion Date: | April 2014 (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:
- Singleton pregnancy
- Gestational age between 8 weeks 0 days and 23 weeks, 6 days by best obstetrical estimate
- Mother has a high or moderate risk for trisomy
- Mother is planning to have or has had an amniocentesis or chorionic villus sampling (CVS) procedure
Exclusion Criteria:
- Unavailability of the father to provide a genetic sample (e.g. sperm donor, non-paternity)
- Egg donor used
- Mother or father have known chromosomal abnormalities (including known balanced translocations)
- Participation in the study in a previous pregnancy
- Pregnancy is a result of IVF with pre-implantation genetic diagnosis
Contacts and Locations
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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: NCT01545674
Show 29 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545674
Show 29 Study Locations
Sponsors and Collaborators
Natera, Inc.
Columbia University
George Washington University
Investigators
| Principal Investigator: | Ronald Wapner, MD | Columbia University |
More Information
Additional Information:
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: | October 28, 2014 |
| 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 Trisomy Chromosome Aberrations Chromosome Duplication Pathologic Processes |
ClinicalTrials.gov processed this record on February 27, 2015