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

June 1, 2010
June 2, 2010
February 2007
December 2008   (final data collection date for primary outcome 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. [ 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 ]
Same as current
Complete list of historical versions of study NCT01136369 on ClinicalTrials.gov Archive Site
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Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Samples of the tissue homogenate will be retained and may be used for for further testing.

Probability Sample

Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

  • Breast Neoplasms
  • Breast Diseases
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.

OSNA Breast Cancer System
Intervention: Device: OSNA Breast Cancer System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
496
December 2008
December 2008   (final data collection date for primary outcome measure)

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.).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01136369
OSNA-BC-001
Yes
Carrie Pineda, Sysmex America, Inc
Sysmex America, Inc.
Not Provided
Not Provided
Sysmex America, Inc.
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP