Breast Diseases, Breast Neoplasms
Conditions
Keywords
metastasis, molecular pathology
Brief summary
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.
Interventions
None listed
Sponsors
Sysmex America, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * 18 years of age or older * Diagnosed pre-surgically with T1-T3 or T4 non-inflammatory breast cancer, clinically node positive or node negative upon clinical examination * Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy * Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form.
Exclusion criteria
* Pregnant subjects, confirmed by interview with either subject or treating physician * Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma * Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy * Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 18 months |
| Correlate OSNA results and histology results with the status of non-sentinel lymph nodes. | 18 months |
| Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II). | 18 months |
Countries
United States
Outcome results
None listed