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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05004337

Recruitment Status : Recruiting

First Posted : August 13, 2021

Last Update Posted : August 13, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Natera, Inc.

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
Vanishing Twin Trisomy 21 Trisomy 13 Trisomy 18

Study Design

Layout table for study information

Study Type :	Observational
Estimated 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 :	July 22, 2021
Estimated Primary Completion Date :	December 2023
Estimated Study Completion Date :	December 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Trisomy 13 Down syndrome Trisomy 18

MedlinePlus related topics: Pregnancy Twins, Triplets, Multiple Births

Genetic and Rare Diseases Information Center resources: Chromosomal Triplication Trisomy 18 Trisomy 13

U.S. FDA Resources

Groups and Cohorts

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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Pregnant women carrying a vanishing twin pregnancy

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05004337

Contacts

Layout table for location contacts

Contact: Sophia Vourthis	(650)249-9090 ext 2017	svourthis@natera.com

Locations

Layout table for location information

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Dugoff, MD
Principal Investigator: Lorraine Dugoff, MD

Sponsors and Collaborators

Natera, Inc.

More Information

Layout table for additonal information

Responsible Party:	Natera, Inc.
ClinicalTrials.gov Identifier:	NCT05004337
Other Study ID Numbers:	21-050-NPT
First Posted:	August 13, 2021 Key Record Dates
Last Update Posted:	August 13, 2021
Last Verified:	August 2021

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Down Syndrome Trisomy 13 Syndrome Trisomy 18 Syndrome Trisomy Aneuploidy Chromosome Aberrations Pathologic Processes Chromosome Duplication Intellectual Disability Neurobehavioral Manifestations	Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases

To Top