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Development of a Non-invasive Prenatal Test

This study is currently recruiting participants.
Verified July 2016 by Roche Sequencing Solutions
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451684
First Posted: October 14, 2011
Last Update Posted: July 18, 2016
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.
Information provided by (Responsible Party):
Roche Sequencing Solutions
  Purpose
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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of a Non-invasive Prenatal Test

Further study details as provided by Roche Sequencing Solutions:

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

Estimated Enrollment: 10000
Study Start Date: June 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
This study will include women who have a singleton pregnancy.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01451684


Contacts
Contact: Romielle Aquino 408-209-9098 raquino@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com

Locations
United States, California
Ariosa Diagnostics Recruiting
San Jose, California, United States, 95138
Contact: Romielle Aquino    408-209-9098    raquino@ariosadx.com   
Principal Investigator: Thomas Musci, MD         
Sponsors and Collaborators
Roche Sequencing Solutions
Investigators
Study Director: Thomas Musci, MD Ariosa Diagnostics
  More Information

Responsible Party: Roche Sequencing Solutions
ClinicalTrials.gov Identifier: NCT01451684     History of Changes
Other Study ID Numbers: TD003
First Submitted: October 10, 2011
First Posted: October 14, 2011
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Roche Sequencing Solutions:
pregnancy
fetus
euploid