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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136369
• Other study ID #: OSNA-BC-001
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: June 2, 2010
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: Sysmex America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United 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 permanent section Hematoxylin and Eosin (H&E) and IHC staining.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.).

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). 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.

Locations

Country	Name	City	State
United States	Breast Care Specialist, PC	Allentown	Pennsylvania
United States	Dallas Surgical Group	Dallas	Texas
United States	Central Carolina Surgery, PA	Greensboro	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	WellStar Health Systems	Marietta	Georgia
United States	Nashville Breast Center, PC	Nashville	Tennessee
United States	Beth Israel Medical Center	New York	New York
United States	Washington University Medical School	Saint Louis	Missouri
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Breast Care Specialist, Inc.	Westerville	Ohio
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sysmex America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The time required to perform the trial method will be measured and evaluated for intra-operative use.		2 Years	No