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 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
1 other identifier
observational
2,000
2 countries
14
Brief Summary
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedOctober 16, 2024
October 1, 2024
14.6 years
September 2, 2011
October 11, 2024
Conditions
Keywords
Eligibility Criteria
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.
You may qualify if:
- pregnant between 10 and 22 weeks gestation
- 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
You may not qualify if:
- Fetal demise at time of specimen sampling
- Previous sample donation under this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
Study Sites (14)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Sharp-Rees Stealy Medical Group
San Diego, California, 92101, United States
UCSD
San Diego, California, 92121, United States
Women's Health Care Research
San Diego, California, 92123, United States
Specialty Obstetrics of San Diego
San Diego, California, 92130, United States
Reproductive Genetics Institute
Chicago, Illinois, 60602, United States
University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
The Cooper Health System
Camden, New Jersey, United States
Medical University of South Carolina
Charleston, South Carolina, 29466, United States
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
North York General Hospital
Toronto, Ontario, Canada
Biospecimen
Whole blood specimens will be collected and processed to plasma. DNA will be extracted from the plasma.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Grosu, MD
Sequenom, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 7, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2025
Study Completion
March 1, 2026
Last Updated
October 16, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
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.