Non-Invasive Determination of Fetal Chromosome Abnormalities

Down Syndrome (Trisomy 21) Clinical Trial

Official title:

Non-Invasive Determination of Fetal Chromosome Abnormalities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00891852
• Other study ID #: 110106-1
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2009
• Last updated: April 30, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2009
• Source: Lenetix Medical Screening Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abnormalities.
• and Other Chromosome
• Chromosome Aberrations
• Chromosome Disorders
• Congenital Abnormalities
• Down Syndrome
• Down Syndrome (Trisomy 21)
• Edward's Syndrome (Trisomy 18)
• Klinefelter Syndrome
• Klinefelter Syndrome (47, XXY)
• Patau Syndrome (Trisomy 13)
• Syndrome

Locations

Country	Name	City	State
United States	UVM	Burlington	Vermont
United States	Winthrop University Hospital	Mineola	New York
United States	Atlantic Maternal Fetal Medicine	Moristown	New Jersey
United States	Elite Women's Health	New Hyde Park	New York
United States	Columbia University, NewYork-Presbyterian Hospital	New York	New York
United States	New York Perinatal Associates	New York	New York
United States	Maryland Perinatal Associates	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Lenetix Medical Screening Laboratory

Country where clinical trial is conducted

United States,