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

Completed

• Conditions: Breast Neoplasms; Breast Diseases
• Interventions: Device: OSNA Breast Cancer System

• Registration Number: NCT01136369
• Lead Sponsor: Sysmex America, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-06
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-02
• Last Update Submitted: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

• Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel node dissection.
• Patients who have read and understand the informed consent form and are capable and willing to provide written informed consent.

Exclusion Criteria

• Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast cancers.
• Patients diagnosed with inflammatory breast cancer.
• Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to be done.
• Patients who are pregnant, as confirmed by a patient/treating physician interview.
• Patients with suspicious palpable axillary lymph nodes.
• Patients currently being treated for or previously diagnosed with, another type of carcinoma.
• Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
• Patients who have received pre-operative systemic therapy.
• Patients who are incapable of providing written informed consent.
• Patients who have been judged to be inappropriate by a medical care provider (i.e. surgeon, oncologist, pathologists, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSNA Breast Cancer System	OSNA Breast Cancer System	-

Primary Outcome Measures

Name	Time	Method
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 staining.	2 years
The time required to perform the trial method will be measured and evaluated for intra-operative use.	2 Years

Trial Locations

Locations (11)

Breast Care Specialist, PC; 🇺🇸 Allentown, Pennsylvania, United States

Dallas Surgical Group; 🇺🇸 Dallas, Texas, United States

John Wayne Cancer Institute; 🇺🇸 Santa Monica, California, United States

WellStar Health Systems; 🇺🇸 Marietta, Georgia, United States

Washington University Medical School; 🇺🇸 Saint Louis, Missouri, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

Central Carolina Surgery, PA; 🇺🇸 Greensboro, North Carolina, United States

Breast Care Specialist, Inc.; 🇺🇸 Westerville, Ohio, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Nashville Breast Center, PC; 🇺🇸 Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States