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Characterization of Circulating Tumor Cells (CTCs) to Direct Pre-Operative and Systemic Therapy in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

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City:   Duarte
State:   California
Zip Code:   91010
Conditions:   Locally Advanced Breast Cancer - Metastatic (Stage IV) Breast Cancer - Stage III-IV Breast Cancer or Inflammatory
Purpose:   The purpose of this study is to identify tumor cells in the bloodstream (Circulating Tumor Cells, CTC's) from patient's with locally advanced or metastatic (stage IV) breast cancer. Analyzing the tumor is helpful in guiding therapy; however, research has suggested that the number of tumor cells found in the bloodstream (CTC's) signifies more aggressive behavior and increased difficulty in eliminating the cancer. This research will help to develop better ways to treat breast cancer which could be tailored to a patient and may be adjusted to a patient's individual needs.
Study Summary:   Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell morphology confirmed by collaborating pathologists to select for CTC with the technology allowing for assessment of up to four additional protein expressions on the surface of CTC's. Additional samples at the proposed time points will be placed on ice and sent over to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's for profiling and further analysis. Benefits are only to society, not the individual. Knowledge obtained from applying the two technologies may help with better selection of therapy, early detection of progression, possibly better diagnosis and development of targeted therapeutic agents in the future.
Criteria:   Inclusion Criteria: - Patients must be > 18 years old. - Patients are being treated for breast cancer at City of Hope (COH).
NCT ID:   NCT01048918
Primary Contact:   Principal Investigator
Georg Somlo, MD
City of Hope Medical Center

Backup Contact:   N/A
Location Contact:   Duarte, California 91010
United States

Norma Baker, RN
Phone: 800-826-4673

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   June 17, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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