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

NCT ID: NCT01368744

Last Updated: 2011-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-06-30

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

Conditions

Breast Neoplasms; Breast Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

OSNA Breast Cancer System

OSNA Breast Cancer System

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sysmex America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Sysmex America, Inc

Locations

University of Milan School of Medicine

Milan, Italy, Italy

Countries

Italy

Other Identifiers

OSNA-BC-002

Identifier Type: -

Identifier Source: org_study_id