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

NCT05004337 | Completed

• 1 other identifier: 21-050-NPT
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 21

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

Conditions

Vanishing Twin; Trisomy 21; Trisomy 13; Trisomy 18

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women carrying a vanishing twin pregnancy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (21)

Center for Fetal Medicine & Women's Ultrasound

Los Angeles, California, 90048, United States

Location

Stanford

Palo Alto, California, 94304, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale

New Haven, Connecticut, 06511, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Emerald Coast ObGyn

Panama City, Florida, 32405, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Beaumont

Royal Oak, Michigan, 48073, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack

Neptune City, New Jersey, 07753, United States

Location

St. Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

NYU Long Island

Mineola, New York, 11501, United States

Location

NYU Langone

New York, New York, 10022, United States

Location

Icahn School of Medicine at Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Cedar Health Research

Irving, Texas, 75039, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pregnancy blood samples from vanishing twin pregnancies and buccal samples from born babies in participating pregnancies

MeSH Terms

Conditions

Down Syndrome; Trisomy 13 Syndrome; Trisomy 18 Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases

Study Officials

• Vivienne Souter, MD

  Natera, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 13, 2021
• Study Start: July 22, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

US (21)