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Non-Invasive Screening for Fetal Aneuploidy

This study has been completed.
Sponsor:
Collaborator:
Obstetrix
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT00847990
First received: February 18, 2009
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Down Syndrome
Edwards Syndrome
Other: Maternal blood screening test for fetal aneuploidy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Resource links provided by NLM:


Further study details as provided by Sequenom, Inc.:

Primary Outcome Measures:
  • Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis [ Time Frame: During the 1st and 2nd trimester of pregnancy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma, PBMCs


Estimated Enrollment: 5000
Study Start Date: March 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Maternal blood screening test for fetal aneuploidy
One blood draw of 20 to 30 mL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847990

Locations
United States, Arizona
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
Phoenix Perinatal Associates, Phoenix Arizona Clinic
Phoenix, Arizona, United States, 85014
Obstetric Perinatal Clinic Tucson (WOMB)
Tucson, Arizona, United States, 85712
United States, California
Fetal Diagnostic Center
Laguna Hills, California, United States, 92653
Long Beach Memorial Medical Center - Magella Medical Group
Long Beach, California, United States, 90806
Obstetrix Medical Group of California - Hamilton
San Jose, California, United States, 95124
United States, Colorado
Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center
Denver, Colorado, United States, 80218
Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center
Denver, Colorado, United States, 80220
Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center
Englewood, Colorado, United States, 80113
Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center
Littleton, Colorado, United States, 80122
Obstetrix Medical Group Colorado at Skyridge Medical Center
Lonetree, Colorado, United States, 80124
United States, Georgia
Maternal Fetal Specialists - Northside Atlanta Geogia
Atlanta, Georgia, United States, 303342
Maternal Fetal Specialist of John's Creek
Duluth, Georgia, United States, 30097
Maternal Fetal Specialists - Gwinnett
Lawrenceville, Georgia, United States, 30045
United States, Missouri
Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center
Kansas City, Missouri, United States, 64111
United States, Nevada
Center for Maternal Fetal Medicine - 7 Hills Office
Las Vegas, Nevada, United States, 89052
Center for Maternal Fetal Medicine - Pinto Office
Las Vegas, Nevada, United States, 89106
Center for Maternal Fetal Medicine - Post Road Office
Las Vegas, Nevada, United States, 89148
United States, Tennessee
Regional Obstetrical Consultants, Chattanooga Tennessee
Chattanooga, Tennessee, United States, 37403
Regional Obstetrical Consultants, Knoxville Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Prenatal Group of San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine
Bellevue, Washington, United States, 98004
Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center
Kirkland, Washington, United States, 98034
Obstetrix Medical Group of Washington, Inc
Seattle, Washington, United States, 98104-3405
Sponsors and Collaborators
Sequenom, Inc.
Obstetrix
Investigators
Principal Investigator: Richard Porreco, MD Obstetrix Medical Group of Colorado
Study Director: Thomas J Garite, MD Obstetrix
  More Information

No publications provided

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT00847990     History of Changes
Other Study ID Numbers: SQNM-T21-301
Study First Received: February 18, 2009
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sequenom, Inc.:
Down syndrome
aneuploidy
chromosome abnormality
amniocentesis
chorionic villus sampling
Laboratory Developed Test (LDT)

Additional relevant MeSH terms:
Aneuploidy
Down Syndrome
Syndrome
Abnormalities, Multiple
Chromosome Aberrations
Chromosome Disorders
Congenital Abnormalities
Disease
Genetic Diseases, Inborn
Intellectual Disability
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014