Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy
NCT ID: NCT01140776
Last Updated: 2011-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
100 participants
OBSERVATIONAL
2010-11-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Sysmex America, Inc.
INDUSTRY
Responsible Party
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Sysmex America, Inc
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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OSNA-BC-NEO-001
Identifier Type: -
Identifier Source: org_study_id
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