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Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Sequenom, Inc.
ClinicalTrials.gov Identifier:
NCT00971334
First received: September 1, 2009
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Pregnancy
Aneuploidy
Down Syndrome
Edwards Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Resource links provided by NLM:

MedlinePlus related topics: Down Syndrome
U.S. FDA Resources

Further study details as provided by Sequenom, Inc.:

Biospecimen Retention:   Samples With DNA

Plasma and PBMCs


Enrollment: 2502
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  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 a CVS or amniocentesis procedure and will receive the FISH, karyotype and/or QF-PCR results from the procedure.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971334

  Show 35 Study Locations
Sponsors and Collaborators
Sequenom, Inc.
PRA International
Investigators
Study Director: Allan T Bombard, MD Sequenom, Inc.
  More Information

No publications provided

Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT00971334     History of Changes
Other Study ID Numbers: SQNM-T21-202
Study First Received: September 1, 2009
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sequenom, Inc.:
Down Syndrome
Aneuploidy
Amniocentesis
CVS

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 June 17, 2013