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

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 Overview

• Status: Completed
• Conditions: Breast Neoplasms; Breast Diseases
• Intervention / Treatment: Device: OSNA Breast Cancer System

• Study Type: Observational
• Enrollment (Actual): 496

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute
  • Georgia
    • Marietta, Georgia, United States, 30062
      • Wellstar Health Systems
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical School
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Central Carolina Surgery, PA
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Westerville, Ohio, United States, 43081
      • Breast Care Specialist, Inc.
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Breast Care Specialist, PC
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Breast Center, PC
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Surgical Group
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

OSNA Breast Cancer System

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sysmex America, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (ESTIMATE): June 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2010
• Last Update Submitted That Met QC Criteria: June 2, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: metastasis; molecular pathology
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases
• Other Study ID Numbers: OSNA-BC-001