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

Sponsor:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00826683

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer Chronic Obstructive Pulmonary Disease	Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: at he end of the study (10 months after the beguening of the study) ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	March 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Control group of healthy subjects : simple blood analysis of EPCs	Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures Other Names: Characterization of the EPC by the primary cultures,correlation between initial EPCs and VEGF concentration
Active Comparator: 2 COPD: one initial blood sample and simple clinical follow-up	Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures Other Names: Characterization of the EPC by the primary cultures,correlation between initial EPCs and VEGF concentration
Active Comparator: 3 NSCLC: one initial blood sample and usual clinical follow-up	Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures Other Names: Characterization of the EPC by the primary cultures,correlation between initial EPCs and VEGF concentration

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826683

Contacts

Contact: Boris MELLONI, Professeur

0555058416

boris.melloni@chu-limoges.fr

Locations

France
CHU limoges	Recruiting
Limoges, France, 87042
Contact: Boris MELLONI, professeur 0555058416 boris.melloni@chu-limoges.fr
Principal Investigator: Boris MELLONI, Professeur

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator:

Boris MELLONI, Professor

Service de pneumologie,chu Limoges

More Information

No publications provided

Responsible Party:	Marie SENGELEN /Directrice de la recherche clinique et de l'Innovation, CHU de Limoges
ClinicalTrials.gov Identifier:	NCT00826683 History of Changes
Other Study ID Numbers:	I08002
Study First Received:	January 9, 2009
Last Updated:	October 2, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Non-small cell lung cancer
Endothelial cell progenitor
Angiogenesis
Vascular endothelial cell growth factor

Healthy control
COPD patients
NSCLC patients

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Lung Diseases, Obstructive
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012