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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136369
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : June 3, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Breast Neoplasms Breast Diseases Device: OSNA Breast Cancer System

Study Type : Observational
Actual Enrollment : 496 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
  2. The time required to perform the trial method will be measured and evaluated for intra-operative use. [ Time Frame: 2 Years ]

Biospecimen Retention:   Samples With DNA
Samples of the tissue homogenate will be retained and may be used for for further testing.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136369

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

Responsible Party: Carrie Pineda, Sysmex America, Inc Identifier: NCT01136369     History of Changes
Other Study ID Numbers: OSNA-BC-001
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: June 3, 2010
Last Verified: June 2010

Keywords provided by Sysmex America, Inc.:
molecular pathology

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases