Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients|
- Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Compare performance of the OSNA Breast Cancer System to intraoperative frozen section methods (mandatory) and imprint cytology methods (optional) with standard histopathology results from permanent sections. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Correlate OSNA results and histology results with the status of non‐sentinel lymph nodes. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Samples of the tissue homogenate will be retained and may be used for for further testing.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
OSNA Breast Cancer System
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.
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|