Prenatal Test for Fetal Aneuploidy Detection

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

Completed

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Key information

Conditions

Aneuploidy Abnormalities, Multiple Chromosome Aberrations Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trisomy 21

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

East Bay Perinatal Medical Associates, Oakland, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roche Sequencing Solutions

Industry

Registry information

Official study title

Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 8, 2010
Registry last updated: Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed