Non-Invasive Screening for Fetal Aneuploidy

• Sponsor: Sequenom, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00847990
• Collaborator: Obstetrix (Other)
• Enrollment: 5,000
• Locations: 25
• Duration (Months): 29
• Patients Per Site: 200
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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	Phase
Down Syndrome; Edwards Syndrome	Other: Maternal blood screening test for fetal aneuploidy

Study Design

• Study Type: Observational
• Anticipated 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: Mar 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Desert Good Samaritan Hospital	Mesa	Arizona	United States	85202
2	Banner Good Samaritan Hospital	Phoenix	Arizona	United States	85006
3	Phoenix Perinatal Associates, Phoenix Arizona Clinic	Phoenix	Arizona	United States	85014
4	Obstetric Perinatal Clinic Tucson (WOMB)	Tucson	Arizona	United States	85712
5	Fetal Diagnostic Center	Laguna Hills	California	United States	92653
6	Long Beach Memorial Medical Center - Magella Medical Group	Long Beach	California	United States	90806
7	Obstetrix Medical Group of California - Hamilton	San Jose	California	United States	95124
8	Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center	Denver	Colorado	United States	80218
9	Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center	Denver	Colorado	United States	80220
10	Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center	Englewood	Colorado	United States	80113
11	Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center	Littleton	Colorado	United States	80122
12	Obstetrix Medical Group Colorado at Skyridge Medical Center	Lonetree	Colorado	United States	80124
13	Maternal Fetal Specialists - Northside Atlanta Geogia	Atlanta	Georgia	United States	303342
14	Maternal Fetal Specialist of John's Creek	Duluth	Georgia	United States	30097
15	Maternal Fetal Specialists - Gwinnett	Lawrenceville	Georgia	United States	30045
16	Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center	Kansas City	Missouri	United States	64111
17	Center for Maternal Fetal Medicine - 7 Hills Office	Las Vegas	Nevada	United States	89052
18	Center for Maternal Fetal Medicine - Pinto Office	Las Vegas	Nevada	United States	89106
19	Center for Maternal Fetal Medicine - Post Road Office	Las Vegas	Nevada	United States	89148
20	Regional Obstetrical Consultants, Chattanooga Tennessee	Chattanooga	Tennessee	United States	37403
21	Regional Obstetrical Consultants, Knoxville Tennessee	Knoxville	Tennessee	United States	37920
22	Texas Prenatal Group of San Antonio	San Antonio	Texas	United States	78229
23	Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine	Bellevue	Washington	United States	98004
24	Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center	Kirkland	Washington	United States	98034
25	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sequenom, Inc.
• ClinicalTrials.gov Identifier: NCT00847990
• Other Study ID Numbers: SQNM-T21-301
• First Posted: Feb 20, 2009
• Last Update Posted: Sep 5, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Sequenom, Inc.: Down syndrome; aneuploidy; chromosome abnormality; amniocentesis; chorionic villus sampling; Laboratory Developed Test (LDT)
• Additional relevant MeSH terms: Down Syndrome; Trisomy 18 Syndrome; Syndrome; Aneuploidy

Study Results

No Results Posted as of Sep 5, 2011