Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS)
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| ClinicalTrials.gov Identifier: NCT01545674 |
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Recruitment Status :
Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : September 5, 2021
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Sponsor:
Natera, Inc.
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.
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Brief Summary:
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 or disease | Intervention/treatment |
|---|---|
| Trisomy 13 Trisomy 18 Trisomy 21 Aneuploidy | Procedure: Blood Draw |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial (PreNATUS) |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | April 2014 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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Pregnant Women Blood Draw
Pregnant Women with elevated risk of trisomic pregnancy to donate a blood sample through one time blood draw
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Procedure: Blood Draw
Blood will be drawn from the mother and father |
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). ]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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545674
Locations
Show 29 study locations
Sponsors and Collaborators
Natera, Inc.
Columbia University
George Washington University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Ronald Wapner, MD | Columbia University |
| Responsible Party: | Natera, Inc. |
| ClinicalTrials.gov Identifier: | NCT01545674 |
| Other Study ID Numbers: |
GSN012B 1R44HD062114 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 7, 2012 Key Record Dates |
| Last Update Posted: | September 5, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | A peer reviewed publication is planned from this study. |
Keywords provided by Natera, Inc.:
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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:
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Down Syndrome Trisomy 13 Syndrome Trisomy 18 Syndrome Aneuploidy Trisomy Chromosome Aberrations Pathologic Processes Chromosome Duplication Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |