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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05004337
Other study ID # 21-050-NPT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 Testâ„¢ results suggest increased risk for vanishing twin Exclusion Criteria: - Monozygotic twin pregnancy - Non twin pregnancy - Maternal history of bone marrow or organ transplantation

Study Design


Related Conditions & MeSH terms


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
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