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 Type
OBSERVATIONAL
Enrollment
496
For in vitro diagnostic use only. The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (\>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (\> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (\> 2 mm). Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required.
John Wayne Cancer Institute
Santa Monica, California, United States
WellStar Health Systems
Marietta, Georgia, United States
Washington University Medical School
St Louis, Missouri, United States
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 staining.
Time frame: 2 years
The time required to perform the trial method will be measured and evaluated for intra-operative use.
Time frame: 2 Years
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Beth Israel Medical Center
New York, New York, United States
Central Carolina Surgery, PA
Greensboro, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Breast Care Specialist, Inc.
Westerville, Ohio, United States
Breast Care Specialist, PC
Allentown, Pennsylvania, United States
Nashville Breast Center, PC
Nashville, Tennessee, United States
Dallas Surgical Group
Dallas, Texas, United States
...and 1 more locations