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

This study has been completed.

Sponsor:

Information provided by:

Sysmex America, Inc.

ClinicalTrials.gov Identifier:

NCT01136369

First received: June 1, 2010

Last updated: June 2, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 1, 2010
Last Updated Date	June 2, 2010
Start Date ^ICMJE	February 2007
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 2, 2010)	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. [ Time Frame: 2 years ] [ Designated as safety issue: No ] The time required to perform the trial method will be measured and evaluated for intra-operative use. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01136369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Official Title ^ICMJE	Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Samples of the tissue homogenate will be retained and may be used for for further testing.
Sampling Method	Probability Sample
Study Population	Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
Condition ^ICMJE	Breast Neoplasms Breast Diseases
Intervention ^ICMJE	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.
Study Group/Cohort (s)	OSNA Breast Cancer System Intervention: Device: OSNA Breast Cancer System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	496
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01136369
Other Study ID Numbers ^ICMJE	OSNA-BC-001
Has Data Monitoring Committee	Yes
Responsible Party	Carrie Pineda, Sysmex America, Inc
Study Sponsor ^ICMJE	Sysmex America, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sysmex America, Inc.
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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