Non-invasive Chromosomal Examination of Trisomy Study

Completed

• Conditions: Trisomy 21

• Registration Number: NCT01511458
• Lead Sponsor: Roche Sequencing Solutions

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18955

Inclusion Criteria

1. Subject is at least 18 years old and can provide informed consent.
2. Subject is planning a hospital delivery.
3. 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.
4. 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

1. Subject has known aneuploidy.
2. Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy.
3. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21.	Enrollment to delivery

Trial Locations

Locations (36)

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

East Bay Perinatal Associates; 🇺🇸 Oakland, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Perinatal Diagnostic Center; 🇺🇸 Riverside, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

The Institute of Prenatal Diagnosis and Reproductive Medicine; 🇺🇸 San Gabriel, California, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

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