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VAlidation of a Lower Cost aneUploidy scrEen

NCT03087357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2443

Last updated 2022-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Down Syndrome
  • Trisomy 18
  • Trisomy 13

Interventions

OTHER

SmartNIPT

A novel, non-next generation sequencing (NGS) test that is designed to perform as well as conventional NGS screening while being simpler and less expensive.

Sponsors & Collaborators

  • PerkinElmer, Inc.

    collaborator INDUSTRY

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Glenn E Palomaki, PhD · Women and Infants Hospital of Rhode Island

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2019-11-19
Completion
2020-10-01

Countries

  • United States
  • Canada
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087357 on ClinicalTrials.gov