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Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy

This study has been terminated.
Sponsor:
Information provided by:
Sysmex America, Inc.
ClinicalTrials.gov Identifier:
NCT01140776
First received: June 3, 2010
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  Purpose

The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.


Condition
Breast Neoplasms
Breast Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare performance of the OSNA Breast Cancer System to intraoperative frozen section methods (mandatory) and imprint cytology methods (optional) with standard histopathology results from permanent sections. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Correlate OSNA results and histology results with the status of non‐sentinel lymph nodes. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II). [ Time Frame: 18 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: 100
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  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 after receiving neoadjuvant hormonal/chemotherapy.

Criteria

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • Diagnosed pre‐surgically with T1‐T3 or T4 non‐inflammatory breast cancer, clinically node positive or node negative upon clinical examination
  • Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy
  • Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form.

Exclusion Criteria:

  • Pregnant subjects, confirmed by interview with either subject or treating physician
  • Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
  • Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy
  • Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140776

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Sysmex America, Inc.
  More Information

No publications provided

Responsible Party: Carrie Pineda, Sysmex America, Inc
ClinicalTrials.gov Identifier: NCT01140776     History of Changes
Other Study ID Numbers: OSNA-BC-NEO-001
Study First Received: June 3, 2010
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sysmex America, Inc.:
metastasis
molecular pathology

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

ClinicalTrials.gov processed this record on May 23, 2013