Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy
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|ClinicalTrials.gov Identifier: NCT01140776|
Recruitment Status : Terminated
First Posted : June 9, 2010
Last Update Posted : June 7, 2011
|Condition or disease|
|Breast Neoplasms Breast Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
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.
- 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 ]
- 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 ]
- Correlate OSNA results and histology results with the status of non‐sentinel lymph nodes. [ Time Frame: 18 months ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140776
|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|