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OpenTrials
Completed

NCT Number: NCT00393341

Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer

We propose to quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Peripheral blood will be drawn from the eligible patients. Different type of EPCs will be isolated from the blood and quantitated.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

Accumulating evidence emphasizes the emerging role of circulating endothelial cells (CECs) and endothelial progenitor cells (EPCs) in tumor angiogenesis as surrogate markers and in the efficacy of anti-angiogenic therapies in breast cancer (22-27). Furstenberger et al. (22) reported that CECs were significantly elevated in breast cancer patients and decreased during chemotherapy (anthracycline and/or taxane based). However, EPCs (CD34+/VEGFR-2+) as well as their progenitor cell population CD133+/CD34+ and the population of CD34+ stem cells increased together with VEGF, erythropoietin and angiopoietin-2 levels. Their data suggest that chemotherapy reduces mature CECs, while mobilizing the EPC population. Using real-time PCR and flow cytometry, they also showed that CD146, an endothelial cell specific antigen, was significantly increased in newly diagnosed breast cancer patients compared to healthy controls (23). Other studies also reported increased circulating EPCs in breast cancer patients in addition to CECs (24,25). In another study, circulating EPCs were not increased in cancer patients despite the high plasma VEGF levels (26). Another interesting aspect is that Mancuso et al (27) showed that CEC kinetics correlate with progression-free and overall survival but not circulating progenitor cells in metastatic breast cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of metastatic breast cancer(stage IV), or women with a history of Stage I or II breast cancer disease who are currently disease free Women greater than or equal to 18 years of age Ability to understand and the willingness to sign an informed consent

Exclusion criteria

  • Chemotherapy, radiation, or surgery within the past 4 weeks.

Treatment and study plan

Blood draw

Procedure

Blood sample will be drawn from a vein in the arm.

Primary outcomes

  1. To quantitate endothelial progenitor cells (EPCs) in early and advanced breast cancer patients. Different type of EPCs will be isolated from the blood and quantitated.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Acronym: EPC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 27, 2006
Registry last updated
Aug 31, 2015

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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