Non-Invasive Screening for Fetal Aneuploidy
1 other identifier
observational
5,000
1 country
25
Brief Summary
The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Typical duration for all trials
25 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
First Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 20, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedSeptember 5, 2011
September 1, 2011
2.1 years
February 18, 2009
September 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
During the 1st and 2nd trimester of pregnancy
Study Arms (1)
Pregnant women
Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
Interventions
Eligibility Criteria
Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
You may qualify if:
- Subject is willing to provide written informed consent
- Pregnant female with singleton gestation 18 years of age or older
- Subject agrees to provide a 20 to 30 mL venous blood sample
- Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
- Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy
You may not qualify if:
- Subject lacks the capacity to provide informed consent
- Twins, triplets or other multiple gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Obstetrixcollaborator
Study Sites (25)
Desert Good Samaritan Hospital
Mesa, Arizona, 85202, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006, United States
Phoenix Perinatal Associates, Phoenix Arizona Clinic
Phoenix, Arizona, 85014, United States
Obstetric Perinatal Clinic Tucson (WOMB)
Tucson, Arizona, 85712, United States
Fetal Diagnostic Center
Laguna Hills, California, 92653, United States
Long Beach Memorial Medical Center - Magella Medical Group
Long Beach, California, 90806, United States
Obstetrix Medical Group of California - Hamilton
San Jose, California, 95124, United States
Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center
Denver, Colorado, 80218, United States
Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center
Denver, Colorado, 80220, United States
Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center
Englewood, Colorado, 80113, United States
Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center
Littleton, Colorado, 80122, United States
Obstetrix Medical Group Colorado at Skyridge Medical Center
Lonetree, Colorado, 80124, United States
Maternal Fetal Specialists - Northside Atlanta Geogia
Atlanta, Georgia, 303342, United States
Maternal Fetal Specialist of John's Creek
Duluth, Georgia, 30097, United States
Maternal Fetal Specialists - Gwinnett
Lawrenceville, Georgia, 30045, United States
Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center
Kansas City, Missouri, 64111, United States
Center for Maternal Fetal Medicine - 7 Hills Office
Las Vegas, Nevada, 89052, United States
Center for Maternal Fetal Medicine - Pinto Office
Las Vegas, Nevada, 89106, United States
Center for Maternal Fetal Medicine - Post Road Office
Las Vegas, Nevada, 89148, United States
Regional Obstetrical Consultants, Chattanooga Tennessee
Chattanooga, Tennessee, 37403, United States
Regional Obstetrical Consultants, Knoxville Tennessee
Knoxville, Tennessee, 37920, United States
Texas Prenatal Group of San Antonio
San Antonio, Texas, 78229, United States
Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine
Bellevue, Washington, 98004, United States
Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center
Kirkland, Washington, 98034, United States
Obstetrix Medical Group of Washington, Inc
Seattle, Washington, 98104-3405, United States
Biospecimen
plasma, PBMCs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Porreco, MD
Obstetrix Medical Group of Colorado
- STUDY DIRECTOR
Thomas J Garite, MD
Obstetrix
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 20, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2011
Study Completion
August 1, 2011
Last Updated
September 5, 2011
Record last verified: 2011-09