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OpenTrials
Completed

NCT Number: NCT00898703

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

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

flow cytometry

Other

immunoenzyme technique

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Correlation of CEC and plasma angiogenic factors with response to tumor to a chemotherapy regimen

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
May 12, 2009
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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