Immune Checkpoints in COPD

Asthma Clinical Trial

— CP-COPD  

Official title:

Predictive Role of Immune Checkpoints in COPD Evolution Towards Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654104
• Other study ID #: 361/2020
• Status: Recruiting
• Start date: November 20, 2020
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2022
• Source: University of Catanzaro
• Contact: Luca Gallelli, MD
• Phone: 3339245656
• Email: gallelli[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 10, 2023
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Copd
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• check immune check points
we will evaluate the expression of immune check points

Locations

Country	Name	City	State
Italy	AO Materdomini	Catanzaro	Italia
Italy	Luca Gallelli	Catanzaro	CZ

Sponsors (3)

Lead Sponsor	Collaborator
University of Catanzaro	Azienda Ospedaliera Universitaria Mater Domini, Catanzaro, Azienda Sanitaria Provinciale Di Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD-L1 in bronchoalveolar lavage fluid	to evaluate the expression of PD-L1	1 month
Primary	CTLA-4 in bronchoalveolar lavage fluid	to evaluate the expression of CTLA-4	1 month
Primary	mucin-domain containing-3 (TIM-3)	to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid	1 month
Primary	PD-1 in bronchoalveolar lavage fluid	to evaluate the expression of PD-1	1 month
Secondary	check point and smoke	to evaluate the correlation between PD-L1 expression and cigarette smoke exposure in COPD patients.	1 month