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Immune Checkpoints in COPD (CP-COPD)

U

University of Catanzaro

Status

Enrolling

Conditions

Asthma
Copd
Lung Cancer
Severe ARDS

Treatments

Other: check immune check points

Study type

Observational

Funder types

Other

Identifiers

NCT04654104
361/2020

Details and patient eligibility

About

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.

Full 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).

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Healthy never smokers
Description:
Clinical evaluation of immune check points expression. A prospective study
Treatment:
Other: check immune check points
Smokers with normal lung function
Description:
evaluation of immune check points expression
Treatment:
Other: check immune check points
Lung cancer
Description:
evaluation of immune check points expression
Treatment:
Other: check immune check points
COPD
Description:
evaluation of immune check points expression
Treatment:
Other: check immune check points

Trial contacts and locations

2

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Central trial contact

Luca Gallelli, MD

Data sourced from clinicaltrials.gov

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