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

NCT ID: NCT00770458

Last Updated: 2010-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Down Syndrome (Trisomy 21) Edwards Syndrome (Trisomy 18) Patau Syndrome (Trisomy 13) Turner Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant women

Pregnant women that will undergo standard of care procedures to evaluate fetus for Down Syndrome

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sequenom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Sequenom, Inc.

Principal Investigators

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Allan Bombard, MD

Role: STUDY_DIRECTOR

Sequenom, Inc.

Locations

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UCSD Fetal Care & Genetics Center

La Jolla, California, United States

Site Status

San Diego Perinatal Center

San Diego, California, United States

Site Status

Obstetrix Medical Group of San Jose

San Jose, California, United States

Site Status

Obstetrix Medical Group of Colorado

Denver, Colorado, United States

Site Status

Women & Infants

Providence, Rhode Island, United States

Site Status

A.R.U.P.

Salt Lake City, Utah, United States

Site Status

Obstetrix Medical Group of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SQNM-Trisomy21-0100

Identifier Type: -

Identifier Source: org_study_id

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