Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology

June 6, 2011 updated by: Sysmex America, Inc.

Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology

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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 435 - 20141
        • University of Milan School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Male or female;
  • 18 years of age or older;
  • Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
  • Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.

Exclusion Criteria:

  • Subjects diagnosed pre-surgically with large or locally advanced (T3 & T4) breast cancer;
  • Pregnant subjects, confirmed by interview with either subject or treating physician;
  • Subjects diagnosed with inflammatory breast cancer;
  • Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
  • Subjects with clinically suspicious, palpable axillary lymph nodes;
  • Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
  • Subjects who have received pre-operative systemic therapy;
  • Subjects who are incapable of providing written informed consent;
  • Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
  • Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

Groups: OSNA Breast Cancer System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sysmex America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSNA-BC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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