Studying Blood Samples in Women With Breast Cancer or a History of Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00898703
First received: May 9, 2009
Last updated: December 13, 2012
Last verified: December 2012

May 9, 2009
December 13, 2012
August 2001
March 2007   (final data collection date for primary outcome measure)
Comparison of levels of peripheral blood (PB) circulating endothelial cells (CEC) and plasma angiogenic factors between patients with active, measurable breast cancer vs prior history of breast cancer with no evidence of active disease [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898703 on ClinicalTrials.gov Archive Site
Correlation of CEC and plasma angiogenic factors with response to tumor to a chemotherapy regimen [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Studying Blood Samples in Women With Breast Cancer or a History of Breast Cancer
QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER

RATIONALE: Studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples in women with breast cancer or a history of breast cancer.

OBJECTIVES:

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

women with breast cancer or a history of breast cancer

Breast Cancer
  • Other: flow cytometry
  • Other: immunoenzyme technique
  • Other: laboratory biomarker analysis
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2007
March 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00898703
CDR0000597587, P30CA023074, UARIZ-HSCA01134
Not Provided
Not Provided
University of Arizona
National Cancer Institute (NCI)
Principal Investigator: Alison T. Stopeck, MD University of Arizona
University of Arizona
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP