Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Recruiting

• Conditions: Down Syndrome; Fetal Aneuploidy

• Registration Number: NCT01429389
• Lead Sponsor: Sequenom, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Sharp-Rees Stealy Medical Group; 🇺🇸 San Diego, California, United States

UCSD; 🇺🇸 San Diego, California, United States

Women's Health Care Research; 🇺🇸 San Diego, California, United States

Specialty Obstetrics of San Diego; 🇺🇸 San Diego, California, United States

Reproductive Genetics Institute; 🇺🇸 Chicago, Illinois, United States

University of Iowa Health Care; 🇺🇸 Iowa City, Iowa, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

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