Non-Invasive Screening for Fetal Aneuploidy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00847990 |
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Recruitment Status
:
Completed
First Posted
: February 20, 2009
Last Update Posted
: September 5, 2011
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Sponsor:
Sequenom, Inc.
Collaborator:
Obstetrix
Information provided by (Responsible Party):
Sequenom, Inc.
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Down Syndrome Edwards Syndrome | Other: Maternal blood screening test for fetal aneuploidy |
| Study Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | April 2011 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Down Syndrome
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Maternal blood screening test for fetal aneuploidy
One blood draw of 20 to 30 mL
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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
Information from the National Library of Medicine
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Sequenom, Inc. |
| ClinicalTrials.gov Identifier: | NCT00847990 History of Changes |
| Other Study ID Numbers: |
SQNM-T21-301 |
| First Posted: | February 20, 2009 Key Record Dates |
| Last Update Posted: | September 5, 2011 |
| Last Verified: | September 2011 |
Keywords provided by Sequenom, Inc.:
|
Down syndrome aneuploidy chromosome abnormality |
amniocentesis chorionic villus sampling Laboratory Developed Test (LDT) |
Additional relevant MeSH terms:
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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 |