Development of a Prenatal Test for Fetal Aneuploidy Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01451671
Recruitment Status : Recruiting
First Posted : October 14, 2011
Last Update Posted : July 18, 2016
Information provided by (Responsible Party):
Roche Sequencing Solutions

Brief Summary:
This is an observational study to develop and evaluate a blood based prenatal blood test. Pregnant women confirmed to be carrying a fetus with a chromosomal abnormality will be eligible. Subjects will be asked to provide a blood sample and a limited amount of clinical data that will be recorded on a case report form. All samples and clinical data will be stripped of subject identifiers prior to submission to Ariosa.

Condition or disease
Fetal Complications

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prenatal Test for Fetal Aneuploidy Detection
Study Start Date : November 2010
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Primary Outcome Measures :
  1. Identification of aneuploidy [ Time Frame: At enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

Inclusion Criteria:

  • Subject has singleton pregnancy
  • Subject is confirmed via invasive testing to be carrying a fetus with a chromosomal abnormality
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject (mother) has a known aneuploidy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451671

Contact: Romielle Aquino 408-209-9098
Contact: Thomas Musci, MD 408-229-7500

United States, California
University of California San Diego Completed
San Diego, California, United States, 92037
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Helen How, MD    502-629-7181   
Principal Investigator: Helen How, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Aoy Tomita, PhD    414-955-2355   
Principal Investigator: Aoy Mitchell, PhD         
Sponsors and Collaborators
Roche Sequencing Solutions
Study Chair: Thomas Musci, MD Ariosa Diagnostics

Responsible Party: Roche Sequencing Solutions Identifier: NCT01451671     History of Changes
Other Study ID Numbers: TD002
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Roche Sequencing Solutions:
cell free DNA

Additional relevant MeSH terms:
Chromosome Aberrations
Pathologic Processes