Non-Small Cell Lung CancerPhase 3CBNPC:PCENCT00826683
Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures in people with Non-Small Cell Lung Cancer and Chronic Obstructive Pulmonary Disease, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written consent
- Subject > 18 year old
- No precedent therapy for cancer
- Non-smoker healthy subject or current smoker COPD patients or NSCLC patients
Who cannot join
- Small-cell lung cancer patient
- Radiotherapy, chemotherapy or target therapy for NSCLC
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures
- Keywords
- Non-small cell lung cancer, Endothelial cell progenitor, Angiogenesis, Vascular endothelial cell growth factor, Healthy control, COPD patients, NSCLC patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell culturesBiological
Also called Characterization of the EPC by the primary cultures,correlation between initial, EPCs and VEGF concentration
| Study group | Role | What they receive |
|---|---|---|
| Control group of healthy subjects | Other | Control group of healthy subjects : simple blood analysis of EPCs Receives: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures |
| COPD | Active comparator | COPD: one initial blood sample and simple clinical follow-up Receives: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures |
| NSCLC | Active comparator | NSCLC: one initial blood sample and usual clinical follow-up Receives: Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of EPCs in peripheral blood from NSCLC patients. Comparison with healthy non-smokers patients and smokers with COPD.
Measured: at the end of the first step of the study (2 months after the beguening of the study)
Secondary outcomes (1)
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
Measured: at he end of the study (10 months after the beguening of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris MELLONI, Professor, Principal investigator, Service de pneumologie,chu Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826683
- Sponsor's protocol ID
- I08002
- Acronym
- CBNPC:PCE
- Status last verified
- Oct 2009
- First submitted
- 9 Jan 2009
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Endothelial Progenitor Cells (EPCs) in Peripheral Blood From Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00826683
- Acronym / sponsor ID
- CBNPC:PCE / I08002
- Keywords
- Non-small cell lung cancer, Endothelial cell progenitor, Angiogenesis, Vascular endothelial cell growth factor, Healthy control, COPD patients, NSCLC patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group of healthy subjects | Other | Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell culturesControl group of healthy subjects : simple blood analysis of EPCs |
| COPD | Active comparator | Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell culturesCOPD: one initial blood sample and simple clinical follow-up |
| NSCLC | Active comparator | Biological: Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell culturesNSCLC: one initial blood sample and usual clinical follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written consent
- Subject > 18 year old
- No precedent therapy for cancer
- Non-smoker healthy subject or current smoker COPD patients or NSCLC patients
Key exclusion criteria (2 listed)
- Small-cell lung cancer patient
- Radiotherapy, chemotherapy or target therapy for NSCLC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell culturesAlso: Characterization of the EPC by the primary cultures,correlation between initial, EPCs and VEGF concentration | Biological | COPD, Control group of healthy subjects, NSCLC |
Primary outcome
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)
1 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
Time frame: at he end of the study (10 months after the beguening of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris MELLONI, Professor principal investigator
Service de pneumologie,chu Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enumeration of endothelial cell progenitor in peripheral blood by flow cytometry, Endothelial cell progenitor characterization by primary cell cultures in people with Non-Small Cell Lung Cancer and Chronic Obstructive Pulmonary Disease, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.