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CompletedNCT00393341EPCUpdated Aug 31, 2015

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

An observational study in Breast Cancer Stage IV, Breast Cancer Stage I and Breast Cancer Stage II, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-31.

Sponsored by Indiana University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
68
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 68 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Chemotherapy, radiation, or surgery within the past 4 weeks.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
68 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Case

    Women with breast cancer

    Procedure: Blood Draw

  • Control

    Women without breast cancer

    Procedure: Blood Draw

Interventions

  • ProcedureBlood Draw

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

06

What researchers measure

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

07

Study locations

1 site
  • Indiana University
    Indianapolis, Indiana 46202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00393341
Lead sponsor
Indiana University School of Medicine
Collaborators
Breast Cancer Research Foundation
Responsible party
Kathy Miller (Ballve Lantero Professor of Oncology, Indiana University) — Principal investigator
First posted
Oct 27, 2006
Start date
Oct 2006
Primary completion
May 2009
Completion
Aug 2009
Last update
Aug 31, 2015

Study contacts

George W Sledge, MD
principal investigator · Indiana University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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