Prenatal Test for Fetal Aneuploidy Detection

N/ACompletedNCT01256606

Roche Sequencing Solutions4,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Aneuploidy Trisomy 21

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

East Bay Perinatal Medical Associates

Oakland, California, United States

Prenatal Diagnosis of Northern California

Sacramento, California, United States

University of California - San Diego

San Diego, California, United States

University of California - San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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