Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)
Information source: University Hospital, Limoges
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-small Cell Lung Cancer; Chronic Obstructive Pulmonary Disease
Intervention: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures (Biological)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital, Limoges Official(s) and/or principal investigator(s): Boris MELLONI, Professor, Principal Investigator, Affiliation: Service de pneumologie,chu Limoges
Overall contact: Boris MELLONI, Professeur, Phone: 0555058416, Email: boris.melloni@chu-limoges.fr
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.
Clinical Details
Official title: Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.
Secondary outcome: 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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Boris MELLONI, Professeur, Phone: 0555058416, Email: boris.melloni@chu-limoges.fr
CHU limoges, Limoges 87042, France; Recruiting Boris MELLONI, professeur, Phone: 0555058416, Email: boris.melloni@chu-limoges.fr Boris MELLONI, Professeur, Principal Investigator
Additional Information
Starting date: March 2009
Last updated: October 2, 2009
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