Clinical trial NCT01122524: MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy
Official title: A Prospective, Multi-center Observational Study With Blinded, Nested Case:Control Analyses to Evaluate the Performance of the Verinata Health Prenatal Aneuploidy Diagnostic Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Prenatal Care
Keywords: Trisomy 21
Lead sponsor: Verinata Health, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women undergoing chorionic villus sampling (CVS) or amniocentesis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood.
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Fetal Medicine
state: California
city: San Francisco
country: United States
facility: San Francisco Perinatal Associates
state: California
city: Fort Collins
country: United States
facility: Women's Clinic of Northern Colorado
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: OB/Gyn Specialists of the Palm Beaches
state: Florida
city: Albuquerque
country: United States
facility: New Mexico Consortium for Perinatal Research
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The Women's Hospital of Texas
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Verinata Health, Inc.
name: Amy J Sehnert, MD
role: STUDY_DIRECTOR
References:
citation: http://www.clinchem.org/cgi/content/abstract/clinchem.2011.165910
citation: Bianchi 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.
citation: Bianchi 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.