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

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ClinicalTrials.gov Identifier: NCT00393341
Recruitment Status : Completed
First Posted : October 27, 2006
Last Update Posted : August 31, 2015
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Kathy Miller, Indiana University

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Stage IV Breast Cancer Stage I Breast Cancer Stage II Procedure: Blood Draw

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.

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
Study Start Date : October 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Case
Women with breast cancer
Procedure: Blood Draw
Blood sample will be drawn from a vein in the arm.

Control
Women without breast cancer
Procedure: Blood Draw
Blood sample will be drawn from a vein in the arm.




Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women 18 or older with breast cancer recieving treatment at IUSCC and willing to donate a blood sample and complete consent form.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393341


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Breast Cancer Research Foundation
Investigators
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Principal Investigator: George W Sledge, MD Indiana University
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Responsible Party: Kathy Miller, Ballve Lantero Professor of Oncology, Indiana University
ClinicalTrials.gov Identifier: NCT00393341    
Other Study ID Numbers: 0609-21
IUCRO-0168
First Posted: October 27, 2006    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015
Keywords provided by Kathy Miller, Indiana University:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases