Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

NCT ID: NCT01429389

Last Updated: 2024-10-16

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

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2026-03-31

Brief Summary

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The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Detailed Description

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To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Conditions

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Down Syndrome Fetal Aneuploidy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* pregnant between 10 and 22 weeks gestation
* 18 years of age or older
* provides signed and dated informed consent
* subject is at increased risk for fetal aneuploidy
* subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis
* subject agrees to provide the genetic results of the invasive procedure

Exclusion Criteria

* Fetal demise at time of specimen sampling
* Previous sample donation under this protocol
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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Responsibility Role SPONSOR

Principal Investigators

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Daniel Grosu, MD

Role: STUDY_DIRECTOR

Sequenom, Inc.

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Sharp-Rees Stealy Medical Group

San Diego, California, United States

Site Status RECRUITING

UCSD

San Diego, California, United States

Site Status RECRUITING

Women's Health Care Research

San Diego, California, United States

Site Status RECRUITING

Specialty Obstetrics of San Diego

San Diego, California, United States

Site Status RECRUITING

Reproductive Genetics Institute

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa Health Care

Iowa City, Iowa, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Spectrum Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

The Cooper Health System

Camden, New Jersey, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

North York General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Facility Contacts

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Rachel Copper

Role: primary

205 934-5509

Joseph Biggio, MD

Role: backup

Deebra Smith, MD

Role: primary

310- 423-5860

John Williams, MD

Role: backup

Mary LaPage

Role: primary

619 446-1624

Denis Tarakjian, MD

Role: backup

Jason Chibuck

Role: primary

Andrew Hull, MD

Role: backup

Nora Martinez

Role: primary

858 505-8672

Rovena Reagan, MD

Role: backup

Deborah Malone

Role: primary

858 794-7700

David Dowling, MD

Role: backup

Denise Ginsberg

Role: primary

773 472-4900

Norman Ginsberg, MD

Role: backup

Diedre Fleener

Role: primary

319 356-2913

Kristi Borowski, MD

Role: backup

Ellen Martindell

Role: primary

313 916-3190

Jacquelyn Roberson, MD

Role: backup

Yvonne Edgerly

Role: primary

616 391-5066

Asad Sheikh, MD

Role: backup

Clare Hanson

Role: primary

Meena Khandelwal, MD

Role: backup

Betty Oswald

Role: primary

843 792-0347

Christopher Robinson, MD

Role: backup

Cora Fanning

Role: primary

902 470-7158

Jo-Ann Brock, MD

Role: backup

Clare Gibbons

Role: primary

416 756-6788

Wendy Meschino, MD

Role: backup

Other Identifiers

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SQNM-T21-107

Identifier Type: -

Identifier Source: org_study_id

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