Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)

Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)

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

Study Overview

• Status: Completed
• Conditions: Trisomy 21; Trisomy 18; Trisomy 13; Vanishing Twin

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

• Study Contact: Name: Sophia Vourthis; Phone Number: 650.226.1723; Email: vanish@natera.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Center for Fetal Medicine & Women's Ultrasound
    • Palo Alto, California, United States, 94304
      • Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Panama City, Florida, United States, 32405
      • Emerald Coast OBGYN
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Hackensack
    • New Brunswick, New Jersey, United States, 08901
      • St. Peter's University Hospital
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Mineola, New York, United States, 11501
      • NYU Long Island
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10065
      • Weill Cornell Medicine
    • New York, New York, United States, 10022
      • NYU Langone
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Irving, Texas, United States, 75039
      • Cedar Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a vanishing twin pregnancy

Description

Inclusion Criteria:

• Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin

Exclusion Criteria:

• Monozygotic twin pregnancy
• Non twin pregnancy
• Maternal history of bone marrow or organ transplantation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 years
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.	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.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 Years

Collaborators and Investigators

• Sponsor: Natera, Inc.
• Investigators: Study Chair: Vivienne Souter, MD, Natera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Heart Defects, Congenital; Cardiovascular Abnormalities; Abnormalities, Multiple; Chromosome Disorders; Chromosome Aberrations; Aneuploidy; Chromosome Duplication; Down Syndrome; Trisomy; Trisomy 13 Syndrome; Trisomy 18 Syndrome
• Other Study ID Numbers: 21-050-NPT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No