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
1 other identifier
observational
496
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2007
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedJune 3, 2010
June 1, 2010
1.8 years
June 1, 2010
June 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
OSNA Breast Cancer System
Interventions
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 Criteria
Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
John Wayne Cancer Institute
Santa Monica, California, 90404, United States
WellStar Health Systems
Marietta, Georgia, 30062, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Central Carolina Surgery, PA
Greensboro, North Carolina, 27401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Breast Care Specialist, Inc.
Westerville, Ohio, 43081, United States
Breast Care Specialist, PC
Allentown, Pennsylvania, 18104, United States
Nashville Breast Center, PC
Nashville, Tennessee, 37203, United States
Dallas Surgical Group
Dallas, Texas, 75230, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Biospecimen
Samples of the tissue homogenate will be retained and may be used for for further testing.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2010
First Posted
June 3, 2010
Study Start
February 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 3, 2010
Record last verified: 2010-06