VAlidation of a Lower Cost aneUploidy scrEen

Completed

Conditions studied: Down Syndrome, Trisomy 18, Trisomy 13

In brief

This study will document the detection rate and false positive rate as well as failure rate of a new prenatal screening approach ('Smart NIPT') as described at www.vanadisdx.com and implemented in an academic laboratory with limited molecular testing experience. Testing will be performed on samples from a general risk pregnancy population, with additional high-risk cases added to improve confidence in the detection rate. Additional characteristics of this non-NGS test such as turn-around time, costs (equipment, training, per test), results reporting, fetal sex, fetal fraction, and quality measures will also be examined.

Key facts

Study ID

NCT03087357

Run by

Women and Infants Hospital of Rhode Island

People needed

2443

Starts

2017-10-10

Expected to finish

2020-10-01

Last updated by the study team

2022-09-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years old
• 10-20 weeks gestation
• Low Risk group
• no known aneuploidy risk
• scheduled for cfDNA screen as primary aneuploidy screen
• High Risk group
• positive cfDNA screen
• scheduled to discuss CVS/amniocentesis as confirmatory test

You may not qualify if…

• Triplet or higher order pregnancy
• Low Risk group
• positive nuchal translucency (NT) or abnormal ultrasound
• previous pregnancy with aneuploidy

Where it is running

• Center for Fetal Medicine — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern Memorial Medical Center — Chicago, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• South Shore Hospital — South Weymouth, Massachusetts, United States
• Womens Health Care Group — Oaks, Pennsylvania, United States
• Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas — Houston, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• North York General Hospital — Toronto, Ontario, Canada
• GenoScience Diagnostic — Québec, Quebec, Canada
• University of Genoa - Hospital San Martino — Genova, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.