Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology

This study has been completed.
Sponsor:
Information provided by:
Sysmex America, Inc.
ClinicalTrials.gov Identifier:
NCT01368744
First received: June 6, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.


Condition Intervention
Breast Neoplasms
Breast Diseases
Device: OSNA Breast Cancer System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology

Resource links provided by NLM:


Further study details as provided by Sysmex America, Inc.:

Primary Outcome Measures:
  • Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 150
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

Groups: OSNA Breast Cancer System


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Male or female;
  • 18 years of age or older;
  • Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
  • Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.

Exclusion Criteria:

  • Subjects diagnosed pre-surgically with large or locally advanced (T3 & T4) breast cancer;
  • Pregnant subjects, confirmed by interview with either subject or treating physician;
  • Subjects diagnosed with inflammatory breast cancer;
  • Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
  • Subjects with clinically suspicious, palpable axillary lymph nodes;
  • Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
  • Subjects who have received pre-operative systemic therapy;
  • Subjects who are incapable of providing written informed consent;
  • Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
  • Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368744

Locations
Italy
University of Milan School of Medicine
Milan, Italy, 435 - 20141
Sponsors and Collaborators
Sysmex America, Inc.
  More Information

No publications provided

Responsible Party: Carrie Pineda, Sysmex America, Inc
ClinicalTrials.gov Identifier: NCT01368744     History of Changes
Other Study ID Numbers: OSNA-BC-002
Study First Received: June 6, 2011
Last Updated: June 6, 2011
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Sysmex America, Inc.:
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014