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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01368744
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Sysmex America, Inc.

Tracking Information
First Submitted Date June 6, 2011
First Posted Date June 8, 2011
Last Update Posted Date June 8, 2011
Study Start Date March 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2011)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology
Official Title Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology
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 an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.
Detailed Description Not Provided
Study Type Observational
Study Design 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
  • Breast Neoplasms
  • Breast Diseases
Intervention 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

Study Groups/Cohorts 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 Completed
Estimated Enrollment
 (submitted: June 6, 2011)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01368744
Other Study ID Numbers OSNA-BC-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carrie Pineda, Sysmex America, Inc
Study Sponsor Sysmex America, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Sysmex America, Inc.
Verification Date June 2011