Development of a Non-invasive Prenatal Test

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: NCT01451684
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 aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Condition or disease

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Non-invasive Prenatal Test
Study Start Date : June 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Primary Outcome Measures :
  1. Absence of chromosomal abnormality [ Time Frame: At time of enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include women who have a singleton pregnancy.

Inclusion Criteria:

  • Subject has singleton pregnancy confirmed via evaluation by a healthcare provider
  • Subject is able to provide informed consent
  • Subject is ≥ 18 years of age

Exclusion Criteria:

  • Subject is pregnant with more than one fetus
  • Subject is unwilling to undergo a blood draw

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): NCT01451684

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

United States, California
Ariosa Diagnostics Recruiting
San Jose, California, United States, 95138
Contact: Romielle Aquino    408-209-9098   
Principal Investigator: Thomas Musci, MD         
Sponsors and Collaborators
Roche Sequencing Solutions
Study Director: Thomas Musci, MD Ariosa Diagnostics

Responsible Party: Roche Sequencing Solutions Identifier: NCT01451684     History of Changes
Other Study ID Numbers: TD003
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Roche Sequencing Solutions: