Prenatal Test for Fetal Aneuploidy Detection

Completed

• Conditions: Aneuploidy; Trisomy 21

• Registration Number: NCT01256606
• Lead Sponsor: Roche Sequencing Solutions

Brief Summary

The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

• Subject is 18yrs or older
• Subject has a singleton pregnancy
• Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy
• Subject is able to provide consent

Exclusion Criteria

• Subject is pregnant with more than one fetus
• Subject (mother) has known aneuploidy
• Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer.
• Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection	24 months	Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis.

Trial Locations

Locations (6)

Prenatal Diagnosis of Northern California; 🇺🇸 Sacramento, California, United States

East Bay Perinatal Medical Associates; 🇺🇸 Oakland, California, United States

University of California - San Diego; 🇺🇸 San Diego, California, United States

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

Atlanta Perinatal Consultants; 🇺🇸 Atlanta, Georgia, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States