NCT01140776

Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy

OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (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 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.

Conditions

• Breast Neoplasms
• Breast Diseases

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-06-09
• Last updated: 2011-06-07

Locations

2 sites across 1 country: United States