Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
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 Hematoxylin and Eosin (H&E) and IHC staining.
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Conditions
Breast Neoplasms
Intervention
OSNA Breast Cancer System
Location
John Wayne Cancer Institute
Santa Monica
California
United States
90404
Status
Completed
Source
Sysmex America, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01136369
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:14-0400
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Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Breast Cancer Lymphedema
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Breast Neoplasms
Tumors or cancer of the human BREAST.
Unilateral Breast Neoplasms
Tumors or cancer found specifically in one human BREAST, but not in both.
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
