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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer

Conditions
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Breast Neoplasms, Breast Diseases

Intervention / Treatment
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* Device: OSNA Breast Cancer System


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OSNA Breast Cancer System<br> | Device: OSNA Breast Cancer System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastasis, molecular pathology