Development of a Prenatal Test for Fetal Aneuploidy Detection

Fetal Complications Clinical Trial

Official title:

Prenatal Test for Fetal Aneuploidy Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451671
• Other study ID #: TD002
• Status: Completed
• Start date: November 2010
• Est. completion date: November 2019

Study information

• Verified date: April 2020
• Source: Roche Sequencing Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Fetal Complications

Locations

Country	Name	City	State
United States	Norton Healthcare	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Cindy Cisneros

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of aneuploidy		At enrollment