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NCT01429389 Clinical Trial

Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

Down Syndrome Clinical Trial

Official title:
Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01429389
Other study ID # SQNM-T21-107
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2011
Est. completion date March 2025

Study information
Verified date August 2023
Source Sequenom, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

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 increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date March 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - Fetal demise at time of specimen sampling - Previous sample donation under this protocol

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada IWK Health Centre Halifax Nova Scotia
Canada North York General Hospital Toronto Ontario
United States University of Alabama Birmingham Birmingham Alabama
United States The Cooper Health System Camden New Jersey
United States Medical University of South Carolina Charleston South Carolina
United States Reproductive Genetics Institute Chicago Illinois
United States Henry Ford Hospital Detroit Michigan
United States Spectrum Health Grand Rapids Michigan
United States University of Iowa Health Care Iowa City Iowa
United States Cedars-Sinai Medical Center Los Angeles California
United States Sharp-Rees Stealy Medical Group San Diego California
United States Specialty Obstetrics of San Diego San Diego California
United States UCSD San Diego California
United States Women's Health Care Research San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Sequenom, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

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