Non-invasive Chromosomal Examination of Trisomy Study

Completed

Conditions studied: Trisomy 21

In brief

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.

Key facts

Study ID

NCT01511458

Run by

Roche Sequencing Solutions

People needed

18955

Starts

2012-03-01

Expected to finish

2014-05-01

Last updated by the study team

2014-07-14

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Fetal Diagnostic Institute of the Pacific — Honolulu, Hawaii, United States
• Northshore University Health System — Evanston, Illinois, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Brigham and Women's Hospital - Center for Fetal Medicine and Prenatal Genetics — Boston, Massachusetts, United States
• Minnesota Perinatal Associates — Minneapolis, Minnesota, United States
• Robert Wood Johnson School of Medicine — New Brunswick, New Jersey, United States
• St. Peters University Medical Center — New Brunswick, New Jersey, United States
• Columbia University — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Northwest Perinatal Center — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Thomas Jefferson Univeristy Hospital — Philadelphia, Pennsylvania, United States
• Women's Health Care Group of Pennsylvania — Wynnewood, Pennsylvania, United States
• Partners in Obstetrics and Gynecology — Pawtucket, Rhode Island, United States

Full record on ClinicalTrials.gov

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