Trisomy 21 Clinical Trial
— VANISHOfficial title:
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
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 |
Verified date | December 2023 |
Source | Natera, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Natera, Inc. |
United States,
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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