MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy
MELISSA
A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
1 other identifier
observational
10,000
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 10, 2011
October 1, 2011
1.3 years
May 11, 2010
October 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
10 months
Study Arms (2)
Chromosomal Abnormality
Fetus affected by chromosomal abnormality
No Chromosomal Abnormality
Fetus not affected by chromosomal abnormality
Eligibility Criteria
Pregnant women undergoing chorionic villus sampling (CVS) or amniocentesis
You may qualify if:
- 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
You may not qualify if:
- \- Invasive prenatal procedure (amniocentesis or CVS) performed prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Center for Fetal Medicine
Los Angeles, California, 90048, United States
San Francisco Perinatal Associates
San Francisco, California, 94109, United States
Women's Clinic of Northern Colorado
Fort Collins, Colorado, 80524, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
OB/Gyn Specialists of the Palm Beaches
West Palm Beach, Florida, 33401, United States
New Mexico Consortium for Perinatal Research
Albuquerque, New Mexico, 87109, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
The Women's Hospital of Texas
Houston, Texas, 77054, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Related Publications (3)
http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
BACKGROUNDBianchi DW, Prosen T, Platt LD, Goldberg JD, Abuhamad AZ, Rava RP, Sehnert AJ; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group*. Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma. Obstet Gynecol. 2013 May;121(5):1057-1062. doi: 10.1097/AOG.0b013e31828ba3d8.
PMID: 23635743DERIVEDBianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP; MatErnal BLood IS Source to Accurately diagnose fetal aneuploidy (MELISSA) Study Group. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012 May;119(5):890-901. doi: 10.1097/AOG.0b013e31824fb482.
PMID: 22362253DERIVED
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amy J Sehnert, MD
Verinata Health, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 13, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
October 10, 2011
Record last verified: 2011-10