MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy (MELISSA)

October 6, 2011 updated by: Verinata Health, Inc.

A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test

The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by amniocentesis or chorionic villus sampling (CVS).

Secondary objectives are to assess performance of the test to detect male gender (XY) and other less common aneuploidies (Trisomy 13 (T13), Trisomy 18 (T18), and Turner Syndrome (45, X)) compared to clinical fetal karyotype.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

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
    • California
      • Los Angeles, California, United States, 90048
        • Center for Fetal Medicine
      • San Francisco, California, United States, 94109
        • San Francisco Perinatal Associates
    • Colorado
      • Fort Collins, Colorado, United States, 80524
        • Women's Clinic of Northern Colorado
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Visions Clinical Research
      • West Palm Beach, Florida, United States, 33401
        • OB/GYN Specialists of the Palm Beaches
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Consortium for Perinatal Research
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Texas
      • Houston, Texas, United States, 77054
        • The Women's Hospital of Texas
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

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

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women undergoing chorionic villus sampling (CVS) or amniocentesis

Description

Inclusion Criteria:

  • Age 18 years or older
  • Clinically confirmed viable pregnancy at the time of enrollment
  • Clinically determined gestational age between 8 wks, 0 days and 22 wks, 0 days
  • Referred or planning to undergo CVS or amniocentesis procedure due to risk of fetal aneuploidy based on protocol-specified clinical indicators
  • Able to provide consent for participation using language appropriate forms and consent process

Exclusion Criteria:

- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment

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
Chromosomal Abnormality
Fetus affected by chromosomal abnormality
No Chromosomal Abnormality
Fetus not affected by chromosomal abnormality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
Time Frame: 10 months
10 months

Collaborators and Investigators

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

Sponsor

Verinata Health, Inc.

Investigators

  • Study Director: Amy J Sehnert, MD, Verinata Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (ESTIMATE)

May 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-0006

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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