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

Trisomy 21 Clinical Trial

— VANISH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004337
• Other study ID #: 21-050-NPT
• Status: Completed
• Start date: July 22, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 13
• Trisomy 18
• Trisomy 21

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Montefiore Medical Center	Bronx	New York
United States	Cedar Health Research	Irving	Texas
United States	University of Kansas	Kansas City	Kansas
United States	Center for Fetal Medicine & Women's Ultrasound	Los Angeles	California
United States	NYU Long Island	Mineola	New York
United States	Hackensack	Neptune	New Jersey
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Yale	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Icahn School of Medicine at Mount Sinai Hospital	New York	New York
United States	NYU Langone	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Stanford	Palo Alto	California
United States	Emerald Coast ObGyn	Panama City	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Beaumont	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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