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Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

NCT ID: NCT03608293

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2013-12-31

Brief Summary

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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

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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).

Conditions

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Smokers Human Bronchial Epithelial Cells Lung Pathogenesis Biomarkers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Smokers

Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed

Group Type EXPERIMENTAL

Broncho Alveolar Lavages (BAL)

Intervention Type DIAGNOSTIC_TEST

BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

Non smokers

Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed

Group Type ACTIVE_COMPARATOR

Broncho Alveolar Lavages (BAL)

Intervention Type DIAGNOSTIC_TEST

BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

Interventions

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Broncho Alveolar Lavages (BAL)

BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universite du Littoral Cote d'Opale

OTHER

Sponsor Role collaborator

Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Gosset, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Other Identifiers

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RC-P0014

Identifier Type: -

Identifier Source: org_study_id