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 ] [ 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
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 - Antepartum Testing Unit at Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center | |
| Denver, Colorado, United States, 80218 | |
| 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 - Pinto Office | |
| Las Vegas, Nevada, United States, 89106 | |
| Center for Maternal Fetal Medicine - 7 Hills Office | |
| Las Vegas, Nevada, United States, 89052 | |
| 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 Trisomy Chromosome Aberrations Pathologic Processes Mental Retardation Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Chromosome Duplication |
ClinicalTrials.gov processed this record on May 19, 2013