CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20,960 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02381457
NCT02381457N/ACompleted

SNP-based Microdeletion and Aneuploidy RegisTry

Natera, Inc.·observational·Posted Mar 6, 2015·Updated Jan 29, 2021

In Brief

An observational study for 22q11 Deletion Syndrome and 10 related conditions. Completed, enrolled 20,960 participants across 21 sites in 6 countries.

Detailed Summary

This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and elect Panorama microdeletion and aneuploidy screening as part of their routine care. The primary objective is to evaluate the performance of Single Nucleotide Polymorphism (SNP)-based Non Invasive Prenatal Testing (NIPT) for 22q11.2 microdeletion (DiGeorge syndrome) in this large cohort of pregnant women. This will be done by performing a review of perinatal medical records and obtaining biospecimens after birth to perform genetic diagnostic testing for 22q11.2 deletion. Results from the follow-up specimens will be compared to those obtained by the Panorama screening test to determine test performance. Specific test performance parameters will include: PPV, specificity, and sensitivity.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 6, 2015
Enrollment StartApr 1, 2015
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 11.3 years ago