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Completed No phase listed Observational

Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer

ClinicalTrials.gov ID: NCT01136369

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.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:27 PM EDT

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
Lead sponsor
Sysmex America, Inc.
Industry
Enrollment
496 participants

Conditions and interventions

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.

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