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Sponsors and Collaborators: |
Indiana University School of Medicine Breast Cancer Research Foundation |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00393341 |
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 |
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Breast Cancer Stage IV Breast Cancer Stage I Breast Cancer Stage II |
Procedure: Blood Draw |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yesim Gokmen-Polar, PhD | 317-274-3605 | ypolar@iupui.edu |
Contact: George Sledge, MD | 317-274-1690 | gsledge@iupui.edu |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: George W Sledge, MD |
Principal Investigator: | George W Sledge, MD | Indiana University |
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 |
Breast Cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |