Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

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Key information

Conditions

Down Syndrome (Trisomy 21) Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Down Syndrome Edwards Syndrome (Trisomy 18) Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Intellectual Disability Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Patau Syndrome (Trisomy 13) Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Trisomy 13 Syndrome Trisomy 18 Syndrome Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UCSD Fetal Care & Genetics Center, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject is female
Subject is pregnant
Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure
Subject is willing to provide blood specimen

Exclusion criteria

Subject is not pregnant
Subject is not willing to provide blood specimen
Subject is not haveing aneuploid screening

Treatment and study plan

Primary outcomes

Compare investigational assay results for Down Syndrome to standard of care results.

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 10, 2008
Registry last updated: Jan 6, 2010

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.

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