Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC) (CBNPC:PCE)
Primary Purpose
Non-Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Small Cell Lung Cancer focused on measuring Non-small cell lung cancer, Endothelial cell progenitor, Angiogenesis, Vascular endothelial cell growth factor, Healthy control, COPD patients, NSCLC patients
Eligibility 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
Sites / Locations
- CHU limoges
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
Control group of healthy subjects
COPD
NSCLC
Arm Description
Control group of healthy subjects : simple blood analysis of EPCs
COPD: one initial blood sample and simple clinical follow-up
NSCLC: one initial blood sample and usual clinical follow-up
Outcomes
Primary Outcome Measures
Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.
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
Full Information
NCT ID
NCT00826683
First Posted
January 9, 2009
Last Updated
August 19, 2016
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT00826683
Brief Title
Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)
Acronym
CBNPC:PCE
Official Title
Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease
Keywords
Non-small cell lung cancer, Endothelial cell progenitor, Angiogenesis, Vascular endothelial cell growth factor, Healthy control, COPD patients, NSCLC patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group of healthy subjects
Arm Type
Other
Arm Description
Control group of healthy subjects : simple blood analysis of EPCs
Arm Title
COPD
Arm Type
Active Comparator
Arm Description
COPD: one initial blood sample and simple clinical follow-up
Arm Title
NSCLC
Arm Type
Active Comparator
Arm Description
NSCLC: one initial blood sample and usual clinical follow-up
Intervention Type
Biological
Intervention Name(s)
Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
Other Intervention Name(s)
Characterization of the EPC by the primary cultures,correlation between initial, EPCs and VEGF concentration
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris MELLONI, Professor
Organizational Affiliation
Service de pneumologie,chu Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)
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