Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
- Conditions
- Vanishing TwinTrisomy 13Trisomy 18Trisomy 21
- Registration Number
- NCT05004337
- Lead Sponsor
- Natera, Inc.
- Brief Summary
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 126
- Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin
- Monozygotic twin pregnancy
- Non twin pregnancy
- Maternal history of bone marrow or organ transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT. 2 Years Each complete participant in the study will have multiple maternal blood samples collected, and a child buccal swab. This outcome will use genetic analysis to reflect for each participant if the algorithm correctly or incorrectly identified the LT versus the DT. Accuracy, defined as the number of VT pairs correctly identified as the LT and DT, divided by the total number of VT pairs, will be calculated.
Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT. 2 years A new algorithm will be written to analyze the serial research blood samples to return a fetal fraction of each twin, and identify which twin is the DT verses the LT. The fetal fraction measurement will be a percentage, and it will be measurable, or not measurable for each sample.
- Secondary Outcome Measures
Name Time Method The accuracy of the updated algorithm for the assignment of risk for trisomy 21/18/13 for the LT in DZ twins with a single LT. 3 Years If a sufficient number of trisomy 21/18/13 cases are observed among any of the cases, assess the accuracy of the updated algorithm to correctly determine whether the LT or DT is aneuploidy. Point estimates and 95% confidence intervals for the specificity for the aneuploidy algorithm.
Trial Locations
- Locations (21)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Hackensack
🇺🇸Neptune, New Jersey, United States
Beaumont
🇺🇸Royal Oak, Michigan, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Yale
🇺🇸New Haven, Connecticut, United States
Center for Fetal Medicine & Women's Ultrasound
🇺🇸Los Angeles, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Icahn School of Medicine at Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
St. Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Stanford
🇺🇸Palo Alto, California, United States
NYU Long Island
🇺🇸Mineola, New York, United States
Emerald Coast ObGyn
🇺🇸Panama City, Florida, United States
NYU Langone
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cedar Health Research
🇺🇸Irving, Texas, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States