Development of a Prenatal Test for Fetal Aneuploidy Detection

This study is currently recruiting participants.
Verified January 2013 by Ariosa Diagnostics, Inc
Sponsor:
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01451671
First received: October 10, 2011
Last updated: August 15, 2013
Last verified: January 2013
  Purpose

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
Fetal Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prenatal Test for Fetal Aneuploidy Detection

Resource links provided by NLM:


Further study details as provided by Ariosa Diagnostics, Inc:

Primary Outcome Measures:
  • Identification of aneuploidy [ Time Frame: At enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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

Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451671

Contacts
Contact: Desiree Hollemon, MSN, MPH 503-686-8972 hollemon@ariosadx.com
Contact: Thomas Musci, MD 408-229-7500 tmusci@ariosadx.com

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92037
Contact: Louise Laurent, MD    619-922-7719    llaurent@ucsd.edu   
Principal Investigator: Louise Laurent, MD         
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Helen How, MD    502-629-7181    helen.how@nortonhealthcare.org   
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    avtomita@gmail.com   
Principal Investigator: Aoy Mitchell, PhD         
Sponsors and Collaborators
Ariosa Diagnostics, Inc
Investigators
Study Chair: Thomas Musci, MD Ariosa Diagnostics
  More Information

No publications provided

Responsible Party: Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01451671     History of Changes
Other Study ID Numbers: TD002
Study First Received: October 10, 2011
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ariosa Diagnostics, Inc:
fetal
aneuploidy
non-invasive
prenatal
cell free DNA

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014