Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Brief Title

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Official Title

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Brief Summary

      The purpose of this study is to collect samples for the purpose of developing a prenatal
      aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from
      pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by
      chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff
      aneuploid test will be compared to the chromosomal analysis obtained via CVS or
      amniocentesis.
    



Study Type

Observational




Condition

Pregnancy



Publications

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

Recruitment Information



Estimated Enrollment

2502

Start Date

August 2009

Completion Date

December 2011

Primary Completion Date

September 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Subject is female

          -  Subject is pregnant

          -  Subject is 18 years of age or older

          -  Subject provides a signed and dated informed consent

          -  Subject agrees to provide a 30-50mL blood sample

          -  Subject is at increased risk for Down syndrome or other aneuploidies (greater than or
             equal to 35 years of age at time of delivery, elevated risk by maternal serum markers
             including Triple, Quad and integrated test, fetal birth defects or markers identified
             by ultrasound or family history of aneuploidy).

          -  Subject plans to undergo an amniocentesis and/or CVS procedure

          -  Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the
             invasive procedure will be provided

        Exclusion Criteria:

          -  None
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Allan T Bombard, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00971334

Organization ID

SQNM-T21-202


Responsible Party

Sponsor

Study Sponsor

Sequenom, Inc.

Collaborators

 PRA Health Sciences

Study Sponsor

Allan T Bombard, MD, Study Director, Sequenom, Inc.


Verification Date

February 2012