Status:
COMPLETED
Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Society for Surgical Oncologists
Sysmex America, Inc.
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitati...
Eligibility Criteria
Inclusion
- Female patients, aged 18 and over.
- Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.
Exclusion
- Inability to give informed consent
- Contraindications for breast surgery or biopsy
- Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:
- Female patients, aged 18 and over
- Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
- Patient must be willing to give informed consent
- Patient with no history of malignancy
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00360152
Start Date
August 1 2006
End Date
April 1 2013
Last Update
July 4 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110