Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Small Cell Lung Cancer Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control group of healthy subjects

Control group of healthy subjects : simple blood analysis of EPCs

Group Type OTHER

Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

Intervention Type BIOLOGICAL

COPD

COPD: one initial blood sample and simple clinical follow-up

Group Type ACTIVE_COMPARATOR

Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

Intervention Type BIOLOGICAL

NSCLC

NSCLC: one initial blood sample and usual clinical follow-up

Group Type ACTIVE_COMPARATOR

Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

Intervention Type BIOLOGICAL

Interventions

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Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

Intervention Type BIOLOGICAL

Other Intervention Names

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Characterization of the EPC by the primary cultures,correlation between initial EPCs and VEGF concentration

Eligibility Criteria

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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