Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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).

Groups: OSNA Breast Cancer System

OSNA Breast Cancer System

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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.

Samples of the tissue homogenate will be retained and may be used for for further testing.

Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology

Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology

Sysmex America, Inc.

Carrie Pineda

Symptoms and General Pathology

Neoplasm Metastasis

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology	NCT01368744	Breast Neoplasm... Breast Diseases	OSNA Breast Can...	18 Years -	Sysmex America, Inc.
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer	NCT01136369	Breast Neoplasm... Breast Diseases	OSNA Breast Can...	18 Years -	Sysmex America, Inc.
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology	NCT01368744	Breast Neoplasm... Breast Diseases	OSNA Breast Can...	18 Years -	Sysmex America, Inc.
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology	NCT01368744	Breast Neoplasm... Breast Diseases	OSNA Breast Can...	18 Years -	Sysmex America, Inc.

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