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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368744
• Other study ID #: OSNA-BC-002
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: June 6, 2011
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Sysmex America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	University of Milan School of Medicine	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Sysmex America, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No