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Development of a Non-invasive Prenatal Test

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ariosa Diagnostics, Inc
Sponsor:
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01451684
First received: October 10, 2011
Last updated: July 11, 2014
Last verified: July 2014
  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 Ariosa Diagnostics, Inc:

Primary Outcome Measures:
  • Absence of chromosomal abnormality [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451684

Contacts
Contact: Desiree Hollemon, MSN, MPH 503-686-8972 dhollemon@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: Desiree Hollemon, MSN, MPH    408-686-8972      
Principal Investigator: Thomas Musci, MD         
Sponsors and Collaborators
Ariosa Diagnostics, Inc
Investigators
Study Director: Thomas Musci, MD Ariosa Diagnostics
  More Information

No publications provided

Responsible Party: Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01451684     History of Changes
Other Study ID Numbers: TD003
Study First Received: October 10, 2011
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ariosa Diagnostics, Inc:
pregnancy
fetus
euploid

ClinicalTrials.gov processed this record on November 25, 2014