Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

Not Applicable

Completed

• Conditions: Human Bronchial Epithelial Cells; Smokers; Lung Pathogenesis; Biomarkers
• Interventions: Diagnostic Test: Broncho Alveolar Lavages (BAL)

• Registration Number: NCT03608293
• Lead Sponsor: Lille Catholic University

Brief Summary

Cigarette smoking is a habit that has spread all over the world and is a significant risk factor for many diseases including cardiovascular disease, chronic obstructive pulmonary disease(COPD),asthma and lung cancer.

Evaluation and understanding of tobacco health effects are of major interest worldwide and answer to important societal concerns.

Identification of new biomarkers of exposure to tobacco smoke potentially implicated in COPD or lung carcinogenesis would allow a better observation of tobacco exposed population, thanks to screening establishment at reversible stages of pathological processes.

In this study, we question whether cigarettes smoking alters miRNA profiles of extracellular vesicles (EVs) present in human broncho alveolar lavages (BALs), which could affect surrounding normal bronchial epithelial cells status.

Detailed Description

Extracellular vesicles (EVs) include a variety of nanoscale membranous vesicles (exosomes, microvesicles, microparticles). EVs are released into the interstitial fluid from a wide variety of normal or diseased cells.

Analysis of EVs and their content maybe useful as disease biomarkers as they reflect the contents of cells of origin, differ between normal and diseased tissue and can be reliably detected.

EVs may thus act as biomarkers of diverse pathologies like cancer, and detection of these biomarkers maybe applied to early diagnosis or assessment of prognosis in patients with cancer. EVs indeed contain both mRNAs and non-coding RNAs, such as small regulatory microRNAs (miRNAs).

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2013-07-31
• Study Completion: 2013-12-31
• Status Verified: 2018-07
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• >18 year-old

Exclusion Criteria

• Lack of informed consent
• Drug treatment
• Professional exposure
• Evolutive pregnancy
• Bradycardia
• Respiratory assistance required,
• Diagnosed respiratory distress (e.g. COPD, asthma)
• Infectious pneumopathy
• Bronchial cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non smokers	Broncho Alveolar Lavages (BAL)	Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed
Smokers	Broncho Alveolar Lavages (BAL)	Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed

Primary Outcome Measures

Name	Time	Method
Quantification of target mRNA expression in human bronchial epithelial cells (BEAS-2 B) exposed to EVs isolated from LBA of patients	Through the study completion, an average of 48 months	Quantitative polymerase chain reaction (RT-qPCR) for determination of mRNA expression