Non-Invasive Determination of Fetal Chromosome Abnormalities

Sponsor

Lenetix Medical Screening Laboratory (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00891852

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

142.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome (Trisomy 21) Edward's Syndrome (Trisomy 18) Patau Syndrome (Trisomy 13) Klinefelter Syndrome (47, XXY) and Other Chromosome Abnormalities.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Non-Invasive Determination of Fetal Chromosome Abnormalities

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maryland Perinatal Associates	Rockville	Maryland	United States	20850
2	Atlantic Maternal Fetal Medicine	Moristown	New Jersey	United States	07960
3	Winthrop University Hospital	Mineola	New York	United States	11501
4	Elite Women's Health	New Hyde Park	New York	United States	11042
5	Columbia University, NewYork-Presbyterian Hospital	New York	New York	United States	10022
6	New York Perinatal Associates	New York	New York	United States	10128
7	UVM	Burlington	Vermont	United States	05405