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Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

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ClinicalTrials.gov Identifier: NCT01429389
Recruitment Status : Unknown
Verified October 2016 by Sequenom, Inc..
Recruitment status was:  Recruiting
First Posted : September 7, 2011
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Sequenom, Inc.

Tracking Information
First Submitted Date September 2, 2011
First Posted Date September 7, 2011
Last Update Posted Date October 31, 2016
Study Start Date May 2011
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01429389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy
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
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 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Down Syndrome
  • Fetal Aneuploidy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September¬†6,¬†2011)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01429389
Other Study ID Numbers SQNM-T21-107
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Sequenom, Inc.
Study Sponsor Sequenom, Inc.
Collaborators Not Provided
Investigators
Study Director: Daniel Grosu, MD Sequenom, Inc.
PRS Account Sequenom, Inc.
Verification Date October 2016