Studying Blood Samples in Women With Breast Cancer or a History of Breast Cancer
NCT ID: NCT00898703
Last Updated: 2012-12-17
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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COMPLETED
50 participants
OBSERVATIONAL
2001-08-31
2007-03-31
Brief Summary
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PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.
Detailed Description
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Primary
* To compare peripheral blood (PB) concentrations of circulating endothelial cells (CEC) in women with measurable, active breast cancer to PB concentrations of CEC in a control population of women with a history of breast cancer who are currently without evidence of active disease.
Secondary
* To compare in women with measurable breast cancer the relationship between PB concentrations of CEC prior to and at 3 and 6 weeks following initiation of a new chemotherapy or hormonal therapy, and correlate these values with clinical response to treatment to determine if CEC can be used as a tumor marker or indicator of disease burden.
* To compare PB concentrations of CEC to levels of plasma proteins associated with angiogenesis, including vascular endothelial growth factor, in women with active or a prior history of breast cancer.
OUTLINE: Peripheral blood and plasma samples are collected for analysis of circulating endothelial cells (CEC) and angiogenic growth factor levels. Blood samples from patients initiating a new chemotherapy or hormonal therapy for breast cancer are collected at baseline and at 3 and 6 weeks following the start of treatment. CEC are quantified via flow cytometry and plasma angiogenic markers are assessed via ELISA.
PROJECTED ACCRUAL: A total of 100 patients with active, measurable breast cancer and 100 patients with a prior history of breast cancer will be accrued for this study.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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flow cytometry
immunoenzyme technique
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Receiving treatment for measurable breast cancer at the Arizona Cancer Center Clinic
* Being followed for a prior history of breast cancer (with no evidence of active disease) at the Arizona Cancer Center
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Arizona
OTHER
Principal Investigators
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Alison T. Stopeck, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Countries
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Other Identifiers
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UARIZ-HSCA01134
Identifier Type: -
Identifier Source: secondary_id
CDR0000597587
Identifier Type: -
Identifier Source: org_study_id