Non-Invasive Determination of Fetal Chromosome Abnormalities

Lenetix Medical Screening Laboratory

Status: Unknown

Conditions: Klinefelter Syndrome (47, XXY); and Other Chromosome; Patau Syndrome (Trisomy 13); Down Syndrome (Trisomy 21); Edward's Syndrome (Trisomy 18); Abnormalities.

Study type: Observational

Funder types: Industry

Identifiers

NCT00891852

110106-1

Details and patient eligibility

About

The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (trisomy 21), Edward's syndrome (trisomy 18), Patau syndrome (trisomy 13), Klinefelter syndrome, (47, XXY), and other chromosome abnormalities. Accomplishing that task would reduce the need for invasive amniocentesis and CVS procedures.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• This study is only applicable to women who are between 8 and 30 weeks' gestation and who have been determined increased risk for fetal aneuploidy. In the interest of expediting and simplifying this study, the investigators want only women who have already decided to undergo second-trimester amniocentesis or CVS.

Exclusion criteria

• The only exclusion criteria are those mentioned.