Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Public ClinicalTrials.gov record NCT01136369. 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
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section Hematoxylin and Eosin (H\&E) and IHC staining.
Study identification
- NCT ID
- NCT01136369
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 496 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Jan 31, 2007
- Primary completion
- Nov 30, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Jun 2, 2010
2007 – 2008
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| John Wayne Cancer Institute | Santa Monica | California | 90404 | — |
| WellStar Health Systems | Marietta | Georgia | 30062 | — |
| Washington University Medical School | St Louis | Missouri | 63110 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Central Carolina Surgery, PA | Greensboro | North Carolina | 27401 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Breast Care Specialist, Inc. | Westerville | Ohio | 43081 | — |
| Breast Care Specialist, PC | Allentown | Pennsylvania | 18104 | — |
| Nashville Breast Center, PC | Nashville | Tennessee | 37203 | — |
| Dallas Surgical Group | Dallas | Texas | 75230 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01136369, 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 Jun 2, 2010 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01136369 live on ClinicalTrials.gov.