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

NCT ID: NCT00393341

Last Updated: 2015-08-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Stage IV Breast Cancer Stage I Breast Cancer Stage II

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Women with breast cancer

Blood Draw

Intervention Type PROCEDURE

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

Control

Women without breast cancer

Blood Draw

Intervention Type PROCEDURE

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

Interventions

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Blood Draw

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Breast Cancer Research Foundation

OTHER

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kathy Miller

Ballve Lantero Professor of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George W Sledge, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IUCRO-0168

Identifier Type: -

Identifier Source: secondary_id

0609-21

Identifier Type: -

Identifier Source: org_study_id

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