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Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
This study is currently recruiting participants.
Verified by Indiana University, July 2008
Sponsors and Collaborators: Indiana University School of Medicine
Breast Cancer Research Foundation
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00393341
  Purpose

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.


Condition Intervention
Breast Cancer Stage IV
Breast Cancer Stage I
Breast Cancer Stage II
Procedure: Blood Draw

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Official Title: Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: October 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood Draw
    Blood sample will be drawn from a vein in the arm.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393341

Contacts
Contact: Yesim Gokmen-Polar, PhD 317-274-3605 ypolar@iupui.edu
Contact: George Sledge, MD 317-274-1690 gsledge@iupui.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: George W Sledge, MD            
Sponsors and Collaborators
Indiana University School of Medicine
Breast Cancer Research Foundation
Investigators
Principal Investigator: George W Sledge, MD Indiana University
  More Information

Responsible Party: Indiana University School of Medicine-Division of Hematology/Oncology ( Principal Investigator-Dr. George Sledge )
Study ID Numbers: IUCRO-0168
Study First Received: October 25, 2006
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00393341  
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Breast Cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009