NCT01136369

Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer

Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 496 (actual)
• Sponsor: Sysmex America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Breast Diseases

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2010-06-03
• Last updated: 2010-06-03

Locations

11 sites across 1 country: United States