Non-invasive Chromosomal Examination of Trisomy Study (NEXT)

This study has been completed.
Sponsor:
Collaborator:
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Information provided by (Responsible Party):
Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01511458
First received: January 13, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition
Trisomy 21

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-invasive Chromosomal Examination of Trisomy

Resource links provided by NLM:


Further study details as provided by Ariosa Diagnostics, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18955
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patient with a trisomy 21 pregnancy confirmed by genetic testing.
Control
Patients without a trisomy 21 pregnancy confirmed by either genetic testing or a normal newborn phenotype.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women presenting for combined first trimester screening as part of routine prenatal care

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511458

  Hide Study Locations
Locations
United States, Arizona
Tucson Medical Center
Tucson, Arizona, United States, 85712
United States, California
East Bay Perinatal Associates
Oakland, California, United States, 94609
Stanford University
Palo Alto, California, United States, 94305-5317
Perinatal Diagnostic Center
Riverside, California, United States, 92501
University of California San Diego
San Diego, California, United States, 92037-1300
California Pacific Medical Center
San Francisco, California, United States, 94118
University of California San Francisco
San Francisco, California, United States, 94143
The Institute of Prenatal Diagnosis and Reproductive Medicine
San Gabriel, California, United States, 91776
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
United States, Hawaii
Fetal Diagnostic Institute of the Pacific
Honolulu, Hawaii, United States, 96814
United States, Illinois
Northshore University Health System
Evanston, Illinois, United States, 60201
United States, Kentucky
Norton Healthcare
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Brigham and Women's Hospital - Center for Fetal Medicine and Prenatal Genetics
Boston, Massachusetts, United States, 02115
United States, Minnesota
Minnesota Perinatal Associates
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
St. Peters University Medical Center
New Brunswick, New Jersey, United States, 08901
Robert Wood Johnson School of Medicine
New Brunswick, New Jersey, United States, 08901
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Northwest Perinatal Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Thomas Jefferson Univeristy Hospital
Philadelphia, Pennsylvania, United States, 19107
Women's Health Care Group of Pennsylvania
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Partners in Obstetrics and Gynecology
Pawtucket, Rhode Island, United States, 02860
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
University Hospitals Leuven
Leuven, Belgium
Canada, Alberta
Early Risk Assessment Program - University of Alberta
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
Ottawa Hospital and Research Institute
Ottawa, Ontario, Canada, ON1Kh8L6
University of Toronto
Toronto, Ontario, Canada, M5G1X8
Mount Sinai University
Toronto, Ontario, Canada, M5G 1X5
Italy
University of Perugia
Perugia, Italy, 06132
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333
Maastricht University Medical Center
Maastricht, Netherlands, 6202
Sweden
Sahlgrenska University Medical Center
Gothenburg, Sweden, SE-41685
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Ariosa Diagnostics, Inc
Perinatal Quality Foundation: Nuchal Translucency Quality Review
Investigators
Principal Investigator: Mary E. Norton, MD Stanford University
Principal Investigator: Ronald Wapner, MD Columbia University
  More Information

Additional Information:
Publications:
Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn 2011;31:3-6.
Malone FD, Canick JA, Ball, RH, Nyberg DA, Comstock CH, Bukowski R, et al. First-trimester or second-trimester screening, or both, for Down's syndrome. N Engl J Med 2005;353:2001-11.
Ghanta S, Mitchell ME, Ames M, Hidestrand M, Simpson P, Goetsch M, et al. Non-invasive prenatal detection of trisomy 21 using tandem single nucleotide polymorphisms. PLoS One. 2010;5(10):e13184.

Responsible Party: Ariosa Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01511458     History of Changes
Other Study ID Numbers: TD007
Study First Received: January 13, 2012
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ariosa Diagnostics, Inc:
Pregnancy
Fetal aneuploidy
Trisomy 21
Down Syndrome
Prenatal screening
Non-invasive prenatal testing
First trimester
Combined screening
Nuchal translucency
PAPP-A
hCG
cell free DNA
cf DNA
DNA
Performance characteristics of non-invasive first trimester screening
Harmony Prenatal Test

Additional relevant MeSH terms:
Trisomy
Down Syndrome
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 30, 2014