Status:
TERMINATED
Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy
Lead Sponsor:
Sysmex America, Inc.
Conditions:
Breast Neoplasms
Breast Diseases
Eligibility:
All Genders
18+ years
Brief Summary
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 afte...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01140776
Start Date
November 1 2010
End Date
July 1 2012
Last Update
June 7 2011
Active Locations (2)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030