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Immune Checkpoints in COPD

Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654104
Acronym
CP-COPD
Enrollment
80
Registered
2020-12-04
Start date
2020-11-20
Completion date
2023-12-10
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Copd, Lung Cancer, Severe ARDS

Keywords

systemic diseases

Brief 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 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).

Interventions

OTHERcheck immune check points

we will evaluate the expression of immune check points

Sponsors

Azienda Sanitaria Provinciale Di Catanzaro
CollaboratorOTHER
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
CollaboratorOTHER
University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* • over 18 years of age with suspected diagnosis of pulmonary neoplasia * signed the informed consent

Exclusion criteria

* • infected diseases * interstitiopathy * asthma, * autoimmune diseases, * neoplasia other than inclusion criteria * subjects on glucocorticoid therapy * 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

Design outcomes

Primary

MeasureTime frameDescription
PD-L1 in bronchoalveolar lavage fluid1 monthto evaluate the expression of PD-L1
CTLA-4 in bronchoalveolar lavage fluid1 monthto evaluate the expression of CTLA-4
mucin-domain containing-3 (TIM-3)1 monthto evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid
PD-1 in bronchoalveolar lavage fluid1 monthto evaluate the expression of PD-1

Secondary

MeasureTime frameDescription
check point and smoke1 monthto evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.

Countries

Italy

Contacts

Primary ContactLuca Gallelli, MD
gallelli@unicz.it3339245656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026