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

January 4, 2010 updated by: Sequenom, Inc.
Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Fetal Care & Genetics Center
      • San Diego, California, United States, 92123
        • San Diego Perinatal Center
      • San Jose, California, United States, 95008
        • Obstetrix Medical Group of San Jose
    • Colorado
      • Denver, Colorado, United States, 80218
        • Obstetrix Medical Group of Colorado
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Women & Infants
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • A.R.U.P.
    • Washington
      • Seattle, Washington, United States, 98104
        • Obstetrix Medical Group of Washington

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

Fetal care and genetic counseling patients.

Description

Inclusion Criteria:

  • Subject is female
  • Subject is pregnant
  • Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
  • Subject is willing to provide blood specimen

Exclusion Criteria:

  • Subject is not pregnant
  • Subject is not willing to provide blood specimen
  • Subject is not haveing aneuploid screening

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Pregnant women
Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare investigational assay results for Down Syndrome to standard of care results.
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Sequenom, Inc.

Investigators

  • Study Director: Allan 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

June 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNM-Trisomy21-0100

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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