Non-Invasive Screening for Fetal Aneuploidy

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

Sponsors

Lead Sponsor: Sequenom, Inc.

Collaborator: Obstetrix

Source Sequenom, Inc.
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.

Overall Status Completed
Start Date 2009-03-01
Completion Date 2011-08-01
Primary Completion Date 2011-04-01
Study Type Observational
Primary Outcome
Measure Time Frame
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
Enrollment 5000
Condition
Intervention

Intervention Type: Other

Intervention Name: Maternal blood screening test for fetal aneuploidy

Description: One blood draw of 20 to 30 mL

Arm Group Label: Pregnant women

Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
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
Location Countries

United States

Verification Date

2011-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Pregnant women

Description: 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.

Study Design Info

Observational Model: Case-Only

Time Perspective: Cross-Sectional

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News