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Non-Invasive Determination of Fetal Chromosome Abnormalities

NCT ID: NCT00891852

Last Updated: 2009-05-01

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

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lenetix Medical Screening Laboratory

INDUSTRY

Sponsor Role lead

Responsible Party

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Lenetix, Inc.

Principal Investigators

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Stephen A Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Lenetix, Inc.

Locations

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Maryland Perinatal Associates

Rockville, Maryland, United States

Site Status RECRUITING

Atlantic Maternal Fetal Medicine

Moristown, New Jersey, United States

Site Status RECRUITING

Winthrop University Hospital

Mineola, New York, United States

Site Status RECRUITING

Elite Women's Health

New Hyde Park, New York, United States

Site Status RECRUITING

Columbia University, NewYork-Presbyterian Hospital

New York, New York, United States

Site Status RECRUITING

New York Perinatal Associates

New York, New York, United States

Site Status RECRUITING

UVM

Burlington, Vermont, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Elizabeth Kramer, GC

Role: primary

[email protected]
301-251-8611

Diane London, Perinatal Nurse

Role: primary

[email protected]
973-971-7080

Martin Chavez, MD

Role: primary

[email protected]
516-663-3020

Jonathan D Herman, MD

Role: primary

[email protected]
516-358-1200

Erica Speigel, GC

Role: primary

[email protected]
212-305-1327

Anne Van Der Veer

Role: backup

[email protected]
212-305-1327

Daniel Saltzman, MD

Role: primary

[email protected]
201-370-5277

Stephen A Brown, MD

Role: primary

[email protected]
802-656-4775

Other Identifiers

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110106-1

Identifier Type: -

Identifier Source: org_study_id

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