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

August 19, 2016 updated by: University Hospital, Limoges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group of healthy subjects
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: COPD
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: NSCLC
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
at the end of the first step of the study (2 months after the beguening of the study)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
at he end of the study (10 months after the beguening of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I08002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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