Environmental Pollutants in COPD and Lung Cancer
Mitochondrial Dysfunction and Immune Checkpoints in Chronic Obstructive Pulmonary Disease (COPD) and Lung Cancer: the Role of Environmental Pollutants
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Bruno D'Agostino, MD, PhD
- Phone Number: +393472601620
- Email: bruno.dagostino@unicampania.it
Study Locations
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Napoli, Italy, 80131
- Recruiting
- Cardarelli Hospital
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Contact:
- Giuseppe Failla, MD
- Phone Number: +390817473391
- Email: giuseppe.failla@aocardarelli.it
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients of both sexes and over the age of 18 years
- Clinical diagnosis of suspected lung cancer
Exclusion Criteria:
- Patients with infectious diseases,
- Patients with interstitiopathy
- Patients with autoimmune diseases
- Patients with cancers not covered by the inclusion criteria
- subjects on glucocorticoid therapy
- subjects who cannot undergo bronchial biopsy
- subjects who will not sign informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Immune checkpoints in COPD and lung cancer.
Time Frame: The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year
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Measurement of immune checkpoint PD-L1, PD-1, e CTLA-4 levels in all enrolled subjects.
The relative expression will be calculated by Real-time PCR using the comparative cycle threshold method (Ct) (2 - ΔΔCt).
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The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year
|
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Mitochondrial activity in COPD and lung cancer.
Time Frame: The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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Measurement of mitochondrial dysfunction markers in all enrolled subjects.
ATP levels will be measured by means of the 'ATP bioluminescence assay kit' and the factors 'PTEN-induced kinase 1 (PINK)-Parkin-mediated pathway' (marker of mitophagy) and sirtuins (marker of senescence) by ELISA assay
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The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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Environmental pollutants in COPD and lung cancer.
Time Frame: The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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Measurement of pollutant concentrations in all enrolled subjects.
A fraction of BAL and peripheral blood will be used for the analysis of pollutants deposited on the cell surface and in the supernatant by means of gas chromatography (GC) coupled to mass spectrometry (MS).
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The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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G-quadruplex levels in all enrolled subjects.
Time Frame: The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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Measurement of G-quadruplex levels in all enrolled subjects.
The BG4 antibody will be used to evaluate the formation of G-quadruplex structures.
Laser scanning confocal microscopy will be performed with a laser scanning confocal microscope with a 400X objective and the signal analysed with Fiji software.
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The outcome will be measured once for each included patient after the enrollment through study completion, an average of 3 year.
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Publications and helpful links
General Publications
- Durham AL, Adcock IM. The relationship between COPD and lung cancer. Lung Cancer. 2015 Nov;90(2):121-7. doi: 10.1016/j.lungcan.2015.08.017. Epub 2015 Aug 29.
- Wilkinson TMA. Immune checkpoints in chronic obstructive pulmonary disease. Eur Respir Rev. 2017 Jun 28;26(144):170045. doi: 10.1183/16000617.0045-2017. Print 2017 Jun 30.
- Wasen C, Erlandsson MC, Bossios A, Ekerljung L, Malmhall C, Toyra Silfversward S, Pullerits R, Lundback B, Bokarewa MI. Smoking Is Associated With Low Levels of Soluble PD-L1 in Rheumatoid Arthritis. Front Immunol. 2018 Jul 27;9:1677. doi: 10.3389/fimmu.2018.01677. eCollection 2018.
- Prakash YS, Pabelick CM, Sieck GC. Mitochondrial Dysfunction in Airway Disease. Chest. 2017 Sep;152(3):618-626. doi: 10.1016/j.chest.2017.03.020. Epub 2017 Mar 21.
- Sachdeva K, Do DC, Zhang Y, Hu X, Chen J, Gao P. Environmental Exposures and Asthma Development: Autophagy, Mitophagy, and Cellular Senescence. Front Immunol. 2019 Nov 29;10:2787. doi: 10.3389/fimmu.2019.02787. eCollection 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MITO2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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