Lung CancerCP-COPDNCT04654104
Immune Checkpoints in COPD
An observational study of Lung Cancer and Severe ARDS, run by University of Catanzaro at 2 sites in Italy.
Trial summary
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Severe ARDS, Asthma
- What is being tested?
- check immune check points
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Nov 2020to 10 Dec 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The levels of PD-1, PD-L1 and CTLA-4 will be evaluated by immunofluorescence and by RT-PCR on biopsy samples, which will be taken according to normal clinical practice. The checkpoint levels will be assessed before and after exposure after a medium of smoke also in the macrophages extracted from the BAL, which will be collected according to normal clinical practice, by RT-PCR. The aforementioned experiments will be carried out at the Pharmacology Section of the Department of Experimental Medicine, University of Campania Luigi Vanvitelli, their cost will not be borne by the NHS but will be fully borne by the aforementioned University.
Who may be able to join
- • over 18 years of age with suspected diagnosis of pulmonary neoplasia
- signed the informed consent
Who cannot join
- • infected diseases
- interstitiopathy
- asthma,
- autoimmune diseases,
- neoplasia other than inclusion criteria
- subjects on glucocorticoid therapy
Show all 10Show fewer
- alcohol consumption (>3 alcoholic beverages daily)
- substance abuse
- inability to give written informed consent
- those who will not sign the consent to the processing of personal data
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Luca Gallelli
Catanzaro, CZ, 88100
Luca Gallelli, MD, 0961712322 ext. +39, gallelli@unicz.it
- Recruiting
AO Materdomini
Catanzaro, Italia, 88100
Luca Gallelli, MD, +390961712537, gallelli@unicz.it
About this study
Official title: Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
Read the detailed description
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
Patients will be recruited from from the outpatient clinics of the Pulmonary and Critical Care Medicine department of "Mauro Scarlato" Hospital in Scafati, Italy in collaboration with the Operational Unit of Clinical Pharmacology and Pharmacovigilance of Catanzaro University.
171 patients will be divided according to the results of the anatomopathological examinations into four groups:
- Healthy never smokers
- Smokers with normal lung
- Cancer
- COPD (COPD group was divided in two subgroups: GOLD 1-2 group and GOLD 3-4 group).
- Conditions
- Lung Cancer, Severe ARDS, Asthma, Copd
- Being tested
- check immune check points
- Keywords
- systemic diseases
- Medical subject headings
- Lung Neoplasms, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
check immune check pointsOther
we will evaluate the expression of immune check points
| Study group | Role | What they receive |
|---|---|---|
| Healthy never smokers | Clinical evaluation of immune check points expression. A prospective study Receives: Other: check immune check points | |
| Smokers with normal lung function | evaluation of immune check points expression Receives: Other: check immune check points | |
| Lung cancer | evaluation of immune check points expression Receives: Other: check immune check points | |
| COPD | evaluation of immune check points expression Receives: Other: check immune check points |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1 in bronchoalveolar lavage fluid
to evaluate the expression of PD-L1
Measured: 1 month
CTLA-4 in bronchoalveolar lavage fluid
to evaluate the expression of CTLA-4
Measured: 1 month
mucin-domain containing-3 (TIM-3)
to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid
Measured: 1 month
PD-1 in bronchoalveolar lavage fluid
to evaluate the expression of PD-1
Measured: 1 month
Secondary outcomes (1)
check point and smoke
to evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start20 Nov 2020
- Primary completion30 Nov 2020
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654104
- Sponsor's protocol ID
- 361/2020
- Acronym
- CP-COPD
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication of the results
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer
- ClinicalTrials.gov ID
- NCT04654104
- Acronym / sponsor ID
- CP-COPD / 361/2020
- Conditions
- Lung Cancer, Severe ARDS, Asthma, Copd
- Keywords
- systemic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 4 Dec 2020 (actual)
- 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.
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
Detailed description
The aim of this study is to investigate the mechanisms underlying the complex interaction between Chronic obstructive pulmonary disease (COPD) and lung cancer. Therefore, in order to identify a possible role of immune checkpoints not only in the susceptibility to COPD development but also in its evolution towards lung cancer, will be evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.
Although there are many epidemiological studies highlighting the interconnections between COPD and lung cancer and the influence of cigarette smoke, the molecular bases of this association are less well defined. Initially they were thought to be driven just by innate inflammation, however, recent studies have also demonstrated the influence of the adaptive immune system. Despite this, the role of immune checkpoints in chronic lung inflammatory diseases such as COPD is less well understood. COPD is currently the 4th leading cause of death worldwide but is assessed to be the 3rd by the end of 2020 resulting in an economic and social burden that is in continuous progression.
Patients will be recruited from from the outpatient clinics of the Pulmonary and Critical Care Medicine department of "Mauro Scarlato" Hospital in Scafati, Italy in collaboration with the Operational Unit of Clinical Pharmacology and Pharmacovigilance of Catanzaro University.
171 patients will be divided according to the results of the anatomopathological examinations into four groups:
- Healthy never smokers
- Smokers with normal lung
- Cancer
- COPD (COPD group was divided in two subgroups: GOLD 1-2 group and GOLD 3-4 group).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy never smokers | – | Other: check immune check pointsClinical evaluation of immune check points expression. A prospective study |
| Smokers with normal lung function | – | Other: check immune check pointsevaluation of immune check points expression |
| Lung cancer | – | Other: check immune check pointsevaluation of immune check points expression |
| COPD | – | Other: check immune check pointsevaluation of immune check points expression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The levels of PD-1, PD-L1 and CTLA-4 will be evaluated by immunofluorescence and by RT-PCR on biopsy samples, which will be taken according to normal clinical practice. The checkpoint levels will be assessed before and after exposure after a medium of smoke also in the macrophages extracted from the BAL, which will be collected according to normal clinical practice, by RT-PCR. The aforementioned experiments will be carried out at the Pharmacology Section of the Department of Experimental Medicine, University of Campania Luigi Vanvitelli, their cost will not be borne by the NHS but will be fully borne by the aforementioned University.
Key inclusion criteria (2 listed)
- • over 18 years of age with suspected diagnosis of pulmonary neoplasia
Key exclusion criteria (10 listed)
- • infected diseases
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 |
|---|---|---|
| check immune check pointswe will evaluate the expression of immune check points | Other | COPD, Healthy never smokers, Lung cancer, Smokers with normal lung function |
Primary outcome
PD-L1 in bronchoalveolar lavage fluid
Time frame: 1 month
to evaluate the expression of PD-L1
CTLA-4 in bronchoalveolar lavage fluid
Time frame: 1 month
to evaluate the expression of CTLA-4
mucin-domain containing-3 (TIM-3)
Time frame: 1 month
to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid
PD-1 in bronchoalveolar lavage fluid
Time frame: 1 month
to evaluate the expression of PD-1
1 secondary outcome
check point and smoke
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Yes. publication of the results
Related trials for Lung Cancer
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Severe ARDS, run by University of Catanzaro at 2 sites in Italy.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Gallelli, MD (3339245656, gallelli@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-L1 in bronchoalveolar lavage fluid (time frame: 1 month). The study lists 4 primary outcomes in all. 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 7 Nov 2022.