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NCT06808880 · ClinicalTrials.gov registry record
EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)
A clinical trial of Single Gene NIPT, sponsored by Natera.
- Recruiting
- Registry status
- 4,000
- Enrollment target
- 18
- Study locations
NCT06808880: Recruiting study of Single Gene NIPT, sponsored by Natera.
NCT06808880 is a study of Single Gene NIPT that is actively recruiting participants, run by Natera. The registered enrollment target is 4,000 participants. The trial reports 18 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06808880, a study of Single Gene NIPT, is actively recruiting participants, sponsored by Natera.
- RECRUITING
- Registry status
- 4,000 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis (CF), spinal muscular atrophy (SMA), Sickle cell disease, alpha thalassemia (a-thalassemia) and beta thalassemia (b-thalassemia) could provide information about the possibility that a child will be born with a serious health condition, in some cases in the absence of reproductive partner screening. In order to develop a test for this purpose, investigators will collect blood samples and medical information from pregnant women who have pregnancies at higher risk for single gene disorders, such as those who are carriers for these conditions or affected by these conditions themselves, medical data from their reproductive partners in some cases, and either genetic testing results or a cheek swab sample from the newborn(s).
Primary Outcome
The sgNIPT assay call, high risk or low risk; will be compared to the genetic outcome of the fetus/ fetuses Affected; or Not Affected; as determined by prenatal genetic testing, post-natal genetic testing or genetic testing performed on the newborn cheek swab sample. Sensitivity, PPV, NPV, and no call rates will be assessed.
Conditions Studied
Interventions
- DEVICE Single-gene Noninvasive Prenatal Testing (sgNIPT)
Study Locations (18)
New York
- NYU Langone Hospital - Garden City
- Northwell (Northshore/LIJ) - New Hyde Park
- NYU Langone - New York
- Icahn School of Medicine at Mount Sinai - New York
- Weill Medical College of Cornell University - New York
- University of Rochester - Rochester
California
- Cedars Sinai Prenatal Diagnosis Center - Los Angeles
- Center for Fetal Medicine and Womens Ultrasound - Los Angeles
- Natera Inc - San Carlos
- University of California San Francisco - San Francisco
Texas
- Austin Maternal Fetal Medicine/St. Davids Healthcare - Austin
- University of Texas Medical Branch (UTMB) - Galveston
- PEDIATRIX Medical Services, Inc. Master + Houston - Stafford
New Jersey
- Capital Health - Lawrenceville
- Rutgers Robert Wood Johnson Medical School - New Brunswick
Arizona
- Valley Perinatal - Glendale
Florida
- Orlando Health Inc. (Winnie Palmer Hsopital) - Orlando
Mississippi
- UMMC WH Univerity Center For Fetal Medicine - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2024-01-25 |
| Est. Completion | 2026-02 |
What NCT06808880 shows while recruiting
NCT06808880 is an observational study that tracks outcomes without assigning an intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Single Gene NIPT appearing as the primary indexed condition, and to 1 intervention - of which Single-gene Noninvasive Prenatal Testing (sgNIPT) is the first listed.
NCT06808880 lists 18 locations in 7 states (New York, California, Texas).
Frequently Asked Questions
What is clinical trial NCT06808880 about?
NCT06808880 is a clinical study titled "EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)". The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis (CF), spinal muscular atrophy (SMA), Sickle cell disease, alpha thalassem...
What is the current status of trial NCT06808880?
This trial is currently recruiting. The enrollment target is 4,000 participants. The study started on 2024-01-25. Estimated completion is 2026-02.
What conditions does trial NCT06808880 study?
This clinical trial studies the following conditions: Single Gene NIPT.
What interventions are being tested in trial NCT06808880?
The interventions under investigation include: Single-gene Noninvasive Prenatal Testing (sgNIPT) (DEVICE).
Who is sponsoring clinical trial NCT06808880?
This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06808880 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Mississippi, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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