Non-invasive Chromosomal Examination of Trisomy Study
Public ClinicalTrials.gov record NCT01511458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Non-invasive Chromosomal Examination of Trisomy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01511458
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 18,955 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2012 (Type not available)
- Primary completion
- Nov 2013 (Actual)
- Completion
- May 2014 (Actual)
- Last update posted
- Jul 14, 2014
2012 – 2014
United States locations
- U.S. sites
- 26
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| East Bay Perinatal Associates | Oakland | California | 94609 | — |
| Stanford University | Palo Alto | California | 94305-5317 | — |
| Perinatal Diagnostic Center | Riverside | California | 92501 | — |
| University of California San Diego | San Diego | California | 92037-1300 | — |
| California Pacific Medical Center | San Francisco | California | 94118 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| The Institute of Prenatal Diagnosis and Reproductive Medicine | San Gabriel | California | 91776 | — |
| Christiana Care Health System | Newark | Delaware | 19718 | — |
| Altus Research | Lake Worth | Florida | 33461 | — |
| Fetal Diagnostic Institute of the Pacific | Honolulu | Hawaii | 96814 | — |
| Northshore University Health System | Evanston | Illinois | 60201 | — |
| Norton Healthcare | Louisville | Kentucky | 40202 | — |
| Brigham and Women's Hospital - Center for Fetal Medicine and Prenatal Genetics | Boston | Massachusetts | 02115 | — |
| Minnesota Perinatal Associates | Minneapolis | Minnesota | 55407 | — |
| Robert Wood Johnson School of Medicine | New Brunswick | New Jersey | 08901 | — |
| St. Peters University Medical Center | New Brunswick | New Jersey | 08901 | — |
| Columbia University | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Northwest Perinatal Center | Portland | Oregon | 97225 | — |
| Oregon Health Sciences University | Portland | Oregon | 97239 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Thomas Jefferson Univeristy Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Women's Health Care Group of Pennsylvania | Wynnewood | Pennsylvania | 19096 | — |
| Partners in Obstetrics and Gynecology | Pawtucket | Rhode Island | 02860 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01511458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2014 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01511458 live on ClinicalTrials.gov.