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Non-Invasive Screening for Fetal Aneuploidy
This study has been completed.
Sponsor:
Sequenom, Inc.
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
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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 ]
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 (Adult, Senior) |
| Sexes 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
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
| 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 |
Keywords provided by Sequenom, Inc.:
|
Down syndrome aneuploidy chromosome abnormality |
amniocentesis chorionic villus sampling Laboratory Developed Test (LDT) |
Additional relevant MeSH terms:
|
Syndrome Down Syndrome Aneuploidy Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Chromosome Aberrations |
ClinicalTrials.gov processed this record on June 28, 2017