Status:
COMPLETED
Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Whole Fetal Cells From Maternal Peripheral Blood
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Baylor College of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Copy Number Abnormality
Prenatal Diagnosis
Eligibility:
FEMALE
18+ years
Brief Summary
Amniocentesis (amnio) and chorionic villus sampling (CVS) can reliably detect many smaller DNA/genetic abnormalities that cannot be reliably diagnosed by cell-free noninvasive prenatal testing (NIPT) ...
Detailed Description
This is a revision to a project entitled "Prenatal Genetic Diagnosis by Genomic Sequencing: A Prospective Evaluation." This study proposes to test the utility and accuracy of a new form of cell-based ...
Eligibility Criteria
Inclusion
- Have already had a CVS or amniocentesis (blood sample collected \>= 7 days after procedure).
- Have already received an abnormal (case) or normal (control) CMA/karyotype/FISH result from the CVS or amniocentesis.
Exclusion
- Unavailability of maternal blood sample at least 7 days post-procedure.
- Language barrier (non-English or Spanish speaking and no adequate interpreter)
- Maternal age of less than 18 years
- Higher order multiple pregnancy (triplet or greater)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 20 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04285814
Start Date
September 1 2020
End Date
July 20 2023
Last Update
January 29 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032
2
Baylor College of Medicine
Houston, Texas, United States, 77030