Status:
COMPLETED
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Lead Sponsor:
Sysmex America, Inc.
Conditions:
Breast Neoplasms
Breast Diseases
Eligibility:
All Genders
18+ years
Brief Summary
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 Hemato...
Eligibility Criteria
Inclusion
- Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.
- Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.
Exclusion
- Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.
- Patients diagnosed with inflammatory breast cancer.
- Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.
- Patients who are pregnant, as confirmed by a patient/treating physician interview.
- Patients with suspicious palpable axillary lymph nodes.
- Patients currently being treated for or previously diagnosed with, another type of carcinoma.
- Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
- Patients who have received pre-operative systemic therapy.
- Patients who are incapable of providing written informed consent.
- Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT01136369
Start Date
February 1 2007
End Date
December 1 2008
Last Update
June 3 2010
Active Locations (11)
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1
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
2
WellStar Health Systems
Marietta, Georgia, United States, 30062
3
Washington University Medical School
St Louis, Missouri, United States, 63110
4
Beth Israel Medical Center
New York, New York, United States, 10003