Non-Invasive Screening for Fetal Aneuploidy

Down Syndrome Clinical Trial

Official title:

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847990
• Other study ID #: SQNM-T21-301
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: September 1, 2011
• Start date: March 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject lacks the capacity to provide informed consent

• Twins, triplets or other multiple gestation

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Aneuploidy
• Down Syndrome
• Edwards Syndrome
• Syndrome

Intervention

Other:
• Maternal blood screening test for fetal aneuploidy
One blood draw of 20 to 30 mL

Locations

Country	Name	City	State
United States	Maternal Fetal Specialists - Northside Atlanta Geogia	Atlanta	Georgia
United States	Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine	Bellevue	Washington
United States	Regional Obstetrical Consultants, Chattanooga Tennessee	Chattanooga	Tennessee
United States	Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center	Denver	Colorado
United States	Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center	Denver	Colorado
United States	Maternal Fetal Specialist of John's Creek	Duluth	Georgia
United States	Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center	Englewood	Colorado
United States	Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center	Kansas City	Missouri
United States	Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center	Kirkland	Washington
United States	Regional Obstetrical Consultants, Knoxville Tennessee	Knoxville	Tennessee
United States	Fetal Diagnostic Center	Laguna Hills	California
United States	Center for Maternal Fetal Medicine - 7 Hills Office	Las Vegas	Nevada
United States	Center for Maternal Fetal Medicine - Pinto Office	Las Vegas	Nevada
United States	Center for Maternal Fetal Medicine - Post Road Office	Las Vegas	Nevada
United States	Maternal Fetal Specialists - Gwinnett	Lawrenceville	Georgia
United States	Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center	Littleton	Colorado
United States	Obstetrix Medical Group Colorado at Skyridge Medical Center	Lonetree	Colorado
United States	Long Beach Memorial Medical Center - Magella Medical Group	Long Beach	California
United States	Desert Good Samaritan Hospital	Mesa	Arizona
United States	Banner Good Samaritan Hospital	Phoenix	Arizona
United States	Phoenix Perinatal Associates, Phoenix Arizona Clinic	Phoenix	Arizona
United States	Texas Prenatal Group of San Antonio	San Antonio	Texas
United States	Obstetrix Medical Group of California - Hamilton	San Jose	California
United States	Obstetrix Medical Group of Washington, Inc	Seattle	Washington
United States	Obstetric Perinatal Clinic Tucson (WOMB)	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	Obstetrix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No