Clinical trial NCT01136369: Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Official title: Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Breast Diseases
Keywords: metastasis
molecular pathology
Lead sponsor: Sysmex America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: The time required to perform the trial method will be measured and evaluated for intra-operative use.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Marietta
country: United States
facility: WellStar Health Systems
state: Georgia
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Greensboro
country: United States
facility: Central Carolina Surgery, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Westerville
country: United States
facility: Breast Care Specialist, Inc.
state: Ohio
city: Allentown
country: United States
facility: Breast Care Specialist, PC
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Breast Center, PC
state: Tennessee
city: Dallas
country: United States
facility: Dallas Surgical Group
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: