Clinical trial NCT05004337: Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
Official title: Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vanishing Twin
Trisomy 21
Trisomy 13
Trisomy 18
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women carrying a vanishing twin pregnancy

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.
timeFrame: 2 Years
Secondary outcomes:
measure: 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.
timeFrame: 3 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Fetal Medicine & Women's Ultrasound
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Panama City
country: United States
facility: Emerald Coast ObGyn
state: Florida
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Neptune
country: United States
facility: Hackensack
state: New Jersey
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Mineola
country: United States
facility: NYU Long Island
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Irving
country: United States
facility: Cedar Health Research
state: Texas
Study officials:
affiliation: Natera, Inc.
name: Vivienne Souter, MD
role: STUDY_CHAIR
References: