Immune Checkpoints in COPD

NCT04654104 | Unknown DMC

• 1 other identifier: 361/2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer; Severe ARDS; Asthma; Copd

Keywords

systemic diseases

Outcome Measures

Primary Outcomes (4)

• PD-L1 in bronchoalveolar lavage fluid

  to evaluate the expression of PD-L1

  1 month

• CTLA-4 in bronchoalveolar lavage fluid

  to evaluate the expression of CTLA-4

  1 month

• mucin-domain containing-3 (TIM-3)

  to evaluate the expression of mucin-domain containing-3 (TIM-3) in bronchoalveolar lavage fluid

  1 month

• PD-1 in bronchoalveolar lavage fluid

  to evaluate the expression of PD-1

  1 month

Secondary Outcomes (1)

• check point and smoke

  1 month

Study Arms (4)

Healthy never smokers

Clinical evaluation of immune check points expression. A prospective study

Other: check immune check points

Smokers with normal lung function

evaluation of immune check points expression

Other: check immune check points

Lung cancer

evaluation of immune check points expression

Other: check immune check points

COPD

evaluation of immune check points expression

Other: check immune check points

Interventions

check immune check points OTHER

we will evaluate the expression of immune check points

COPD; Healthy never smokers; Lung cancer; Smokers with normal lung function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• infected diseases
• interstitiopathy
• asthma,
• autoimmune diseases,
• 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

Sponsors & Collaborators

• University of Catanzaro: lead
• Azienda Sanitaria Provinciale Di Catanzaro: collaborator
• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: collaborator

Study Sites (2)

Luca Gallelli

Catanzaro, CZ, 88100, Italy

RECRUITING

AO Materdomini

Catanzaro, Italia, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luca Gallelli, MD

CONTACT

3339245656; gallelli@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 4, 2020
• Study Start: November 20, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 10, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months

Locations

IT (2)