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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.

Outcome Time Frame:

at the end of the first step of the study (2 months after the beguening of the study)

Safety Issue:

No

Principal Investigator

Boris MELLONI, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service de pneumologie,chu Limoges

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

I08002

NCT ID:

NCT00826683

Start Date:

March 2009

Completion Date:

January 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Chronic Obstructive Pulmonary Disease
  • Non-small cell lung cancer
  • Endothelial cell progenitor
  • Angiogenesis
  • Vascular endothelial cell growth factor
  • Healthy control
  • COPD patients
  • NSCLC patients
  • Carcinoma, Non-Small-Cell Lung
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Neoplasms
  • Lung Diseases, Obstructive

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