Non-Invasive Screening for Fetal Aneuploidy

Brief Title

Non-Invasive Screening for Fetal Aneuploidy

Official Title

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

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.
    



Study Type

Observational


Primary Outcome

Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis


Condition

Down Syndrome

Intervention

Maternal blood screening test for fetal aneuploidy

Study Arms / Comparison Groups

 Pregnant women
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

5000

Start Date

March 2009

Completion Date

August 2011

Primary Completion Date

April 2011

Eligibility 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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Richard Porreco, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00847990

Organization ID

SQNM-T21-301


Responsible Party

Sponsor

Study Sponsor

Sequenom, Inc.

Collaborators

 Obstetrix

Study Sponsor

Richard Porreco, MD, Principal Investigator, Obstetrix Medical Group of Colorado


Verification Date

September 2011