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

Sponsor

Sequenom, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00770458

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

142.9

Patients Per Site

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome (Trisomy 21) Edwards Syndrome (Trisomy 18) Patau Syndrome (Trisomy 13) Turner Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Pregnant women Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome

Outcome Measures

Primary Outcome Measures

Compare investigational assay results for Down Syndrome to standard of care results. [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Fetal Care & Genetics Center	La Jolla	California	United States	92037
2	San Diego Perinatal Center	San Diego	California	United States	92123
3	Obstetrix Medical Group of San Jose	San Jose	California	United States	95008
4	Obstetrix Medical Group of Colorado	Denver	Colorado	United States	80218
5	Women & Infants	Providence	Rhode Island	United States	02903
6	A.R.U.P.	Salt Lake City	Utah	United States	84108
7	Obstetrix Medical Group of Washington	Seattle	Washington	United States	98104