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

This study has been completed.
Sponsor:
Information provided by:
Sysmex America, Inc.
ClinicalTrials.gov Identifier:
NCT01136369
First received: June 1, 2010
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Breast Neoplasms
Breast Diseases
 Device: OSNA Breast Cancer System

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sysmex America, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The time required to perform the trial method will be measured and evaluated for intra-operative use. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples of the tissue homogenate will be retained and may be used for for further testing.


Enrollment: 496
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136369

Locations
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.
  More Information

No publications provided

Responsible Party: Carrie Pineda, Sysmex America, Inc
ClinicalTrials.gov Identifier: NCT01136369     History of Changes
Other Study ID Numbers: OSNA-BC-001
Study First Received: June 1, 2010
Last Updated: June 2, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Sysmex America, Inc.:
metastasis
molecular pathology

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

ClinicalTrials.gov processed this record on May 21, 2013