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

Sponsor

Natera, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05004337

Collaborator

(none)

200

Enrollment

Location

28.3

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vanishing Twin Trisomy 21 Trisomy 13 Trisomy 18

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 22, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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. [2 years]
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.
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT. [2 Years]
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.

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Natera, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Natera, Inc.

ClinicalTrials.gov Identifier:

NCT05004337

Other Study ID Numbers:

21-050-NPT

First Posted:

Aug 13, 2021

Last Update Posted:

Aug 13, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021