Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

August 7, 2023 updated by: Sequenom, Inc.

Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • IWK Health Centre
        • Contact:
        • Principal Investigator:
          • Jo-Ann Brock, MD
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • North York General Hospital
        • Contact:
        • Principal Investigator:
          • Wendy Meschino, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Principal Investigator:
          • Joseph Biggio, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Deebra Smith, MD
          • Phone Number: 310-423-5860
        • Principal Investigator:
          • John Williams, MD
      • San Diego, California, United States, 92101
        • Recruiting
        • Sharp-Rees Stealy Medical Group
        • Principal Investigator:
          • Denis Tarakjian, MD
        • Contact:
          • Mary LaPage
          • Phone Number: 619-446-1624
      • San Diego, California, United States, 92121
        • Recruiting
        • UCSD
        • Contact:
        • Principal Investigator:
          • Andrew Hull, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Women's Health Care Research
        • Principal Investigator:
          • Rovena Reagan, MD
        • Contact:
      • San Diego, California, United States, 92130
        • Recruiting
        • Specialty Obstetrics of San Diego
        • Contact:
        • Principal Investigator:
          • David Dowling, MD
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Recruiting
        • Reproductive Genetics Institute
        • Contact:
          • Denise Ginsberg
          • Phone Number: 773-472-4900
        • Principal Investigator:
          • Norman Ginsberg, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Contact:
        • Principal Investigator:
          • Kristi Borowski, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Jacquelyn Roberson, MD
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health
        • Contact:
          • Yvonne Edgerly
          • Phone Number: 616-391-5066
        • Principal Investigator:
          • Asad Sheikh, MD
    • New Jersey
      • Camden, New Jersey, United States
    • South Carolina
      • Charleston, South Carolina, United States, 29466
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Christopher Robinson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women between 10 and 22 weeks of gestation who are scheduled to undergo a CVS or amniocentesis procedure and will receive the fetal FISH, karyotype and/or QF-PCR results from the procedure.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Investigators

  • Study Director: Daniel Grosu, MD, Sequenom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimated)

September 7, 2011

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNM-T21-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Samples are used for research and development of a noninvasive prenatal test. However, samples used for publications will have data shared as defined by journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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