NCT01368744

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• 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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.

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). Groups: OSNA Breast Cancer System

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-06-08
• Last updated: 2011-06-08

Locations

1 site across 1 country: Italy