- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451671
Development of a Prenatal Test for Fetal Aneuploidy Detection
April 28, 2020 updated by: Cindy Cisneros
Prenatal Test for Fetal Aneuploidy Detection
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92037
- University of California San Diego
-
-
Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Healthcare
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women carrying a fetus with an abnormal chromosomal condition that has been confirmed by invasive testing.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification of aneuploidy
Time Frame: At enrollment
|
At enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
October 10, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (Estimate)
October 14, 2011
Study Record Updates
Last Update Posted (Actual)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 28, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TD002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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