Status:
RECRUITING
Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy
Lead Sponsor:
Sequenom, Inc.
Conditions:
Down Syndrome
Fetal Aneuploidy
Eligibility:
FEMALE
18+ years
Brief Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Detailed Description
To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an ...
Eligibility Criteria
Inclusion
- pregnant between 10 and 22 weeks gestation
- 18 years of age or older
- provides signed and dated informed consent
- subject is at increased risk for fetal aneuploidy
- subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
- subject agrees to provide the genetic results of the invasive procedure
Exclusion
- Fetal demise at time of specimen sampling
- Previous sample donation under this protocol
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT01429389
Start Date
May 1 2011
End Date
March 1 2026
Last Update
October 16 2024
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Sharp-Rees Stealy Medical Group
San Diego, California, United States, 92101
4
UCSD
San Diego, California, United States, 92121