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

Sponsor

Sysmex America, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01136369

Collaborator

(none)

496

Enrollment

Locations

Duration (Months)

45.1

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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 permanent section Hematoxylin and Eosin (H&E) and IHC staining.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Breast Diseases	Device: OSNA Breast Cancer System

Study Design

Study Type:

Observational

Actual Enrollment :

496 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	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). 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.

Arm

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). 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	John Wayne Cancer Institute	Santa Monica	California	United States	90404
2	WellStar Health Systems	Marietta	Georgia	United States	30062
3	Washington University Medical School	Saint Louis	Missouri	United States	63110
4	Beth Israel Medical Center	New York	New York	United States	10003
5	Central Carolina Surgery, PA	Greensboro	North Carolina	United States	27401
6	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
7	Breast Care Specialist, Inc.	Westerville	Ohio	United States	43081
8	Breast Care Specialist, PC	Allentown	Pennsylvania	United States	18104
9	Nashville Breast Center, PC	Nashville	Tennessee	United States	37203
10	Dallas Surgical Group	Dallas	Texas	United States	75230
11	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Sysmex America, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01136369

Other Study ID Numbers:

OSNA-BC-001

First Posted:

Jun 3, 2010

Last Update Posted:

Jun 3, 2010

Last Verified:

Jun 1, 2010

Keywords provided by , ,

metastasis

molecular pathology

Additional relevant MeSH terms:

Breast Neoplasms

Breast Diseases

Study Results

No Results Posted as of Jun 3, 2010