Development of a Prenatal Test for Fetal Aneuploidy Detection

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:
NCT01451671
First received: October 10, 2011
Last updated: July 11, 2014
Last verified: July 2014
  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: 1500
Study Start Date: November 2010
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 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

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
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: 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: July 11, 2014
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 September 22, 2014