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Clinical Trials/NCT00826683
NCT00826683
Completed
Phase 3

Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients

University Hospital, Limoges1 site in 1 country140 target enrollmentMarch 2009

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Non-Small Cell Lung Cancer
Sponsor
University Hospital, Limoges
Enrollment
140
Locations
1
Primary Endpoint
Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.

Detailed Description

The aim of this study is to study blood circulating levels bone-marrow-derived progenitor cells (EPCS). In a first phase, EPCs will be detected in healthy non-smokers volunteers to validate flow cytometry method (n=25). In addition, EPC will e characterized by primary cultures to analyze EPC-specific markers. In a second phase, EPCs will detect in peripheral blood from 50 patients with Chronic Obstructive Pulmonary Disease (COPD) and 50 patients with non-small cell lung cancers (NSCLC). Primary cultures will be made to confirm EPCS isolation. Methods: EPCs will be numerated by flow cytometry using CD133, CD146, CD34, CD45 and VEGFR2 antibodies. Primary cultures will be used to identify EPCs at 5-days culture by the same markers. In addition, for BPCO et NSCLC patients, Vascular endothelial cell growth factor (VEGF) concentration will be measured in peripheral sera by ELISA commercial test. Overall survival will be analyzed for NSCLC in function of initial EPCs concentration. Correlation will be studied between initial VEGF serum concentration and EPCs level. This study focus on the possibility that EPC determination in peripheral blood could be used as a surrogate marker of standard or antiangiogenic treatment in NSCLC.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
January 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Limoges
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Signed written consent
  • Subject \> 18 year old
  • No precedent therapy for cancer
  • Non-smoker healthy subject or current smoker COPD patients or NSCLC patients

Exclusion Criteria

  • Small-cell lung cancer patient
  • Radiotherapy, chemotherapy or target therapy for NSCLC

Outcomes

Primary Outcomes

Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.

Time Frame: at the end of the first step of the study (2 months after the beguening of the study)

Secondary Outcomes

  • Characterization of EPCs by primary cultures. Correlation between initial EPCs and VEGF concentration in COPD and NSCLC patients Overall survival in NSCLC patients in relation to EPCs initial numeration(at he end of the study (10 months after the beguening of the study))

Study Sites (1)

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