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Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT01048918
Recruitment Status : Recruiting
First Posted : January 14, 2010
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Palo Alto Research Center
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
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.

Condition or disease
Locally Advanced Breast Cancer Metastatic (Stage IV) Breast Cancer Stage III-IV Breast Cancer or Inflammatory

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Circulating Tumor Cells (CTC-s) in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer
Study Start Date : September 2008
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
No Treatment



Primary Outcome Measures :
  1. Targets ER, Her2, and possible M30, VEGFR2, EGFR. Tumor cells found in blood stream. [ Time Frame: Blood will be collected at up to 6 time points: Prior to initiating therapy, 8-12 weeks, 20-24 weeks, and at 9,12 and 24 months after initiation of therapy. ]

Secondary Outcome Measures :
  1. Banking leftover blood. Used for future research purposes that have not yet been determined. [ Time Frame: Future ]

Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Brawerman Center-Outpatient clinics (City of Hope), Pasadena Satellite Office
Criteria

Inclusion Criteria:

  • Patients must be > 18 years old.
  • Patients are being treated for breast cancer at City of Hope (COH).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048918


Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Norma Baker, RN    800-826-4673      
Contact: Michele Kirschenbaum    800 826-4673      
Principal Investigator: Yuan Yuan, MD, PhD         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Palo Alto Research Center
Investigators
Principal Investigator: Yuan Yuan, MD, PhD City of Hope Medical Center

Additional Information:
Publications of Results:
Flores LM, Kindelberger DW, Ligon AH, Cappeletti M, Fiorentino M, Loda M, Cibas ES, Janne PA, Krop IE. Dana-Farber Cancer Institute, Boston, MA; Brigham and Women's Hospital, Boston, MA. Comparison of the Cellsearch Profile Kit (CPK) with the Standard Cellsearch Epithelial Kit (CEK) Demonstrates the CPK Produces Higher Circulating Tumor Cell (CTC) Yields and Is Better Suited for Use in Obtaining CTC's for Molecular Characterization. American Association for Cancer Research 2009; 69(Suppl.): (24). December 15, 2009

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01048918     History of Changes
Other Study ID Numbers: 08128
CA 111359 ( Other Grant/Funding Number: NCI )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Keywords provided by City of Hope Medical Center:
Circulating tumor cells in breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes