Prenatal Test for Fetal Aneuploidy Detection

January 8, 2013 updated by: Roche Sequencing Solutions

Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4000

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
      • Oakland, California, United States, 94609
        • East Bay Perinatal Medical Associates
      • Sacramento, California, United States, 95815
        • Prenatal Diagnosis of Northern California
      • San Diego, California, United States, 92121
        • University of California - San Diego
      • San Francisco, California, United States, 94122
        • University of California - San Francisco
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Perinatal Consultants
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women planning to undergo chorionic villus sampling or amniocentesis for fetal genetic evaluation

Description

Inclusion Criteria:

  • Subject is 18yrs or older
  • Subject has a singleton pregnancy
  • Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
  • Subject is able to provide consent

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has known aneuploidy
  • Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
  • Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Positive for fetal aneuploidy
Negative for fetal aneuploidy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
Time Frame: 24 months
Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.
24 months

Collaborators and Investigators

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

Sponsor

Roche Sequencing Solutions

Investigators

  • Study Director: Ken Song, MD, Ariosa Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (Estimate)

December 8, 2010

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT001

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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