Recruiting

Observational StudySpecimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Sponsor:

Sequenom, Inc.

Code:

NCT01429389

Conditions

Down Syndrome

Fetal Aneuploidy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Down Syndrome

Fetal Aneuploidy

Study ID

NCT01429389

Start date

May, 2011

Status verified date

Oct, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rachel Copper

205 934-5509 rachel.copper@obgyn.uab.edu

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Deebra Smith, MD

310- 423-5860

Sharp-Rees Stealy Medical Group

Recruiting

San Diego, California, United States, 92101

Contacts

Mary LaPage

619 446-1624

UCSD

Recruiting

San Diego, California, United States, 92121

Contacts

Jason Chibuck

jchibuck@ucsd.edu

Women's Health Care Research

Recruiting

San Diego, California, United States, 92123

Contacts

Nora Martinez

858 505-8672 research@womenwellness.com

Specialty Obstetrics of San Diego

Recruiting

San Diego, California, United States, 92130

Contacts

Deborah Malone

858 794-7700 d.malone@specialtyobstetrics.com

Reproductive Genetics Institute

Recruiting

Chicago, Illinois, United States, 60602

Contacts

Denise Ginsberg

773 472-4900

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Diedre Fleener

319 356-2913 deidre-fleener@uiowa.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Ellen Martindell

313 916-3190 emartin1@hfhs.org

Spectrum Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Yvonne Edgerly

616 391-5066

The Cooper Health System

Recruiting

Camden, New Jersey, United States

Contacts

Clare Hanson

hansen-clare@cooperhealth.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29466

Contacts

Betty Oswald

843 792-0347 oswaldbw@musc.edu

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Cora Fanning

902 470-7158 cora.fanning@iwk.nshealth.ca

North York General Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Clare Gibbons

416 756-6788 clare.gibbons@nygh.on.ca

More Information

Sponsor

Sequenom, Inc.

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Keywords

Down syndrome
fetal aneuploidy
trisomy
noninvasive screening test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sequenom, Inc. on 2024-10-16.