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NCT05004337 · ClinicalTrials.gov registry record
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
A clinical trial of Trisomy 21 and Trisomy 18, sponsored by Natera.
- Completed
- Registry status
- 126
- Enrollment target
- 20
- Study locations
NCT05004337: Completed study of Trisomy 21 and Trisomy 18, sponsored by Natera.
NCT05004337 is a study of Trisomy 21 and Trisomy 18 that has completed, run by Natera. The registered enrollment target is 126 participants, below the 842-participant average among 5 other Trisomy 21 trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05004337, a study of Trisomy 21 and Trisomy 18, has completed, sponsored by Natera.
- COMPLETED
- Registry status
- 126 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
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.
Conditions Studied
Study Locations (20)
New York
- NYU Long Island - Mineola
- NYU Langone - New York
- Icahn School of Medicine at Mount Sinai Hospital - New York
- Columbia University - New York
- Weill Cornell Medicine - New York
- Montefiore Medical Center - The Bronx
California
- Center for Fetal Medicine & Women's Ultrasound - Los Angeles
- Stanford - Palo Alto
Michigan
- University of Michigan - Ann Arbor
- Beaumont - Royal Oak
New Jersey
- Hackensack - Neptune City
- St. Peter's University Hospital - New Brunswick
Pennsylvania
- Lehigh Valley Health Network - Allentown
- University of Pennsylvania - Philadelphia
Colorado
- University of Colorado - Aurora
Connecticut
- Yale - New Haven
Delaware
- Christiana Care - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2021-07-22 |
| Est. Completion | 2023-11-29 |
What the finished NCT05004337 record still lists
NCT05004337 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 842-participant average among 5 other Trisomy 21 trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Trisomy 21 appearing as the primary indexed condition, and to 0 interventions.
NCT05004337 names 20 study sites across 11 states, led by New York, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05004337 about?
NCT05004337 is a clinical study titled "Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies". 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
What is the current status of trial NCT05004337?
This trial is currently completed. The enrollment target is 126 participants. The study started on 2021-07-22. Estimated completion is 2023-11-29.
What conditions does trial NCT05004337 study?
This clinical trial studies the following conditions: Trisomy 21, Trisomy 18, Trisomy 13, Vanishing Twin.
Who is sponsoring clinical trial NCT05004337?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05004337 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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