Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Sequenom, Inc.
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT01429389
First received: September 2, 2011
Last updated: April 18, 2016
Last verified: April 2016

September 2, 2011
April 18, 2016
May 2011
December 2016   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01429389 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Aneuploidy for Use in Development of the SEQureDx Trisomy 21 Test in the Detection of the Relative Quantity of Chromosome 21 Circulating Cell-Free DNA Extracted From Maternal Plasma
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.
Non-Probability Sample
Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and/or QF-PCR results from the procedure.
  • Down Syndrome
  • Fetal Aneuploidy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
March 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
United States,   Canada
 
NCT01429389
SQNM-T21-107
No
No
Samples are used for research and development of a noninvasive prenatal test. However, samples used for publications will have data shared as defined by journal.
Sequenom, Inc.
Sequenom, Inc.
Not Provided
Study Director: Daniel Grosu, MD Sequenom, Inc.
Sequenom, Inc.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP