Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
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|ClinicalTrials.gov Identifier: NCT05004337|
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 13, 2021
|Condition or disease|
|Vanishing Twin Trisomy 21 Trisomy 13 Trisomy 18|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
- 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.
- 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.
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
|Contact: Sophia Vourthis||(650)249-9090 ext firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Lorraine Dugoff, MD|
|Principal Investigator: Lorraine Dugoff, MD|