Non-Invasive Screening for Fetal Aneuploidy

September 1, 2011 updated by: Sequenom, Inc.

Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

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

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Desert Good Samaritan Hospital
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Hospital
      • Phoenix, Arizona, United States, 85014
        • Phoenix Perinatal Associates, Phoenix Arizona Clinic
      • Tucson, Arizona, United States, 85712
        • Obstetric Perinatal Clinic Tucson (WOMB)
    • California
      • Laguna Hills, California, United States, 92653
        • Fetal Diagnostic Center
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center - Magella Medical Group
      • San Jose, California, United States, 95124
        • Obstetrix Medical Group of California - Hamilton
    • Colorado
      • Denver, Colorado, United States, 80218
        • Obstetrix Medical Group - Colorado at Presbyterian/St. Luke's Center
      • Denver, Colorado, United States, 80220
        • Obstetrix Medical Group Colorado - Antepartum Testing Unit at Rose Medical Center
      • Englewood, Colorado, United States, 80113
        • Obstetrix Medical Group Colorada - Perinatal Resource Center at Swedish Medical Center
      • Littleton, Colorado, United States, 80122
        • Obstetrix Medical Group - Colorado at Littleton Adventist Hospital Perinatal Care Center
      • Lonetree, Colorado, United States, 80124
        • Obstetrix Medical Group Colorado at Skyridge Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 303342
        • Maternal Fetal Specialists - Northside Atlanta Geogia
      • Duluth, Georgia, United States, 30097
        • Maternal Fetal Specialist of John's Creek
      • Lawrenceville, Georgia, United States, 30045
        • Maternal Fetal Specialists - Gwinnett
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Obstetrix Medical Group of Kansas City, Missouri, Saint Luke's Perinatal Center
    • Nevada
      • Las Vegas, Nevada, United States, 89052
        • Center for Maternal Fetal Medicine - 7 Hills Office
      • Las Vegas, Nevada, United States, 89106
        • Center for Maternal Fetal Medicine - Pinto Office
      • Las Vegas, Nevada, United States, 89148
        • Center for Maternal Fetal Medicine - Post Road Office
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Regional Obstetrical Consultants, Chattanooga Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Regional Obstetrical Consultants, Knoxville Tennessee
    • Texas
      • San Antonio, Texas, United States, 78229
        • Texas Prenatal Group of San Antonio
    • Washington
      • Bellevue, Washington, United States, 98004
        • Obstetrix Medical Group of Washington, Eastside Maternal Fetal Medicine
      • Kirkland, Washington, United States, 98034
        • Obstetrix Medical Group of Washington, MFM Clinic at Evergreen Medical Center
      • Seattle, Washington, United States, 98104-3405
        • Obstetrix Medical Group of Washington, Inc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.

Description

Inclusion Criteria:

  • Subject is willing to provide written informed consent
  • Pregnant female with singleton gestation 18 years of age or older
  • Subject agrees to provide a 20 to 30 mL venous blood sample
  • Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
  • Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy

Exclusion Criteria:

  • Subject lacks the capacity to provide informed consent
  • Twins, triplets or other multiple gestation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pregnant women
Pregnant women who are scheduled to undergo an amniocentesis or CVS procedure and will receive the fetal FISH and/or karyotype results from the procedure.
Other: Maternal blood screening test for fetal aneuploidy
One blood draw of 20 to 30 mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Validate the prenatal aneuploidy LDT with blood samples from pregnant women who are undergoing invasive prenatal diagnosis
Time Frame: During the 1st and 2nd trimester of pregnancy
During the 1st and 2nd trimester of pregnancy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sequenom, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Obstetrix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Porreco, MD, Obstetrix Medical Group of Colorado
  • Study Director: Thomas J Garite, MD, Obstetrix

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SQNM-T21-301

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings