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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Non-Small Cell Lung Cancer
• Interventions: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures

• Registration Number: NCT00826683
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-22
• Study Start: 2009-03
• Status Verified: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group of healthy subjects	Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures	Control group of healthy subjects : simple blood analysis of EPCs
COPD	Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures	COPD: one initial blood sample and simple clinical follow-up
NSCLC	Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures	NSCLC: one initial blood sample and usual clinical follow-up

Primary Outcome Measures

Name	Time	Method
Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.	at the end of the first step of the study (2 months after the beguening of the study)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU limoges; 🇫🇷 Limoges, France