Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

February 15, 2012 updated by: Sequenom, Inc.
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes
      • Paris, France, 75019
        • Hôpital Robert Debré
      • Paris, France, 75019
        • Hôpital Cochin Port Royal
      • Toulouse, France, 31026
        • Hopital Paule de Viguier - CHU Toulouse
      • Tours, France, 37044
        • Centre Hospitalier Regional et Universitaire - Hopital Bretonneau
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604-3302
        • University of South Alabama
    • California
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • San Diego, California, United States, 92123
        • San Diego Perinatal Center
      • San Diego, California, United States, 92121
        • IGO
      • San Diego, California, United States, 92123
        • Women's Healthcare at Frost Street
      • San Diego, California, United States, 92128
        • Poway Womens Care
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33143
        • South Florida Perinatal Medicine
      • Pembroke Pines, Florida, United States, 33323
        • Global Ob/Gyn Centers
      • Sunrise, Florida, United States, 33323
        • Sheridan Clinical Research
      • Sunrise, Florida, United States, 33323
        • Discovery Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Fetal Diagnostic Institution of the Pacific
    • Idaho
      • Boise, Idaho, United States, 83712
        • Women's Clinic
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Reproductive Genetics Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health - Maternal Fetal Medicine
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63117
        • St Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68022
        • Methodist Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
    • Ohio
      • Columbus, Ohio, United States, 43231
        • Complete Healthcare For Women
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Clinical Trials of America
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Kingsport Perinatology
      • Nashville, Tennessee, United States, 37203
        • Perinatal Research Center
      • Nashville, Tennessee, United States, 37203
        • Tenessee Maternal Fetal Medicine
    • Texas
      • Houston, Texas, United States, 77054
        • Houston Perinatal Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

PRA Health Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 15, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNM-T21-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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