Non-invasive Chromosomal Examination of Trisomy Study

The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in a general screened population.

The performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.

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Key information

Conditions

Trisomy 21 Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is at least 18 years old and can provide informed consent.
Subject is planning a hospital delivery.
Subject has a singleton pregnancy with a documented gestational age between 10 weeks, 0 days, and 14 weeks, 2 days, inclusive, at the time of the study blood sample collection.
Subject is planning to undergo combined first trimester prenatal screening that includes NT measurement, and when indicated, serum screening with total or free β-hCG and PAPP-A.

Exclusion criteria

Subject has known aneuploidy.
Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy.
Subject has a twin demise at any gestational age. Twin demise includes any reductions, spontaneous or elective, after sonographic identification of a second (or more) gestational sac. Any clinical, sonographic, or other testing that suggests twin demise would serve as an exclusion criterion.

Treatment and study plan

Primary outcomes

Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21.

Time frame: Enrollment to delivery

Sponsors and collaborators

Lead sponsor

Roche Sequencing Solutions

Industry

Collaborators

Perinatal Quality Foundation: Nuchal Translucency Quality Review

Registry information

Official study title

Non-invasive Chromosomal Examination of Trisomy

Acronym: NEXT

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Jan 18, 2012
Registry last updated: Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed