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

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

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.

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Control group of healthy subjects : simple blood analysis of EPCs
• Active Comparator: 2
  • COPD: one initial blood sample and simple clinical follow-up
• Active Comparator: 3
  • NSCLC: one initial blood sample and usual clinical follow-up

Primary 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)
    Safety Issue?: No

Secondary 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)
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University Hospital, Limoges Other

Overall Clinical Trial Officials and Contacts

Boris MELLONI, Professor Principal Investigator Service de pneumologie,chu Limoges  

Overall Contact: Boris MELLONI, Professeur 0555058416 boris.melloni@chu-limoges.fr

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00826683

Study ID Number: I08002

ClinicalTrials.gov Identifier: NCT00826683

Health Authority: France: Afssaps - French Health Products Safety Agency