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

Completed

Conditions studied: Breast Neoplasms, Breast Diseases

In brief

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.

Key facts

Study ID

NCT01136369

Run by

Sysmex America, Inc.

People needed

496

Starts

2007-02-01

Expected to finish

2008-12-01

Last updated by the study team

2010-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• John Wayne Cancer Institute — Santa Monica, California, United States
• WellStar Health Systems — Marietta, Georgia, United States
• Washington University Medical School — St Louis, Missouri, United States
• Beth Israel Medical Center — New York, New York, United States
• Central Carolina Surgery, PA — Greensboro, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Breast Care Specialist, Inc. — Westerville, Ohio, United States
• Breast Care Specialist, PC — Allentown, Pennsylvania, United States
• Nashville Breast Center, PC — Nashville, Tennessee, United States
• Dallas Surgical Group — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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