Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells (Aerotox-1)

July 24, 2018 updated by: Lille Catholic University

Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smokers
Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed
Diagnostic test: Broncho Alveolar Lavages (BAL)
BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.
Active Comparator: Non smokers
Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed
Diagnostic test: Broncho Alveolar Lavages (BAL)
BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Universite du Littoral Cote d'Opale

Investigators

  • Principal Investigator: Pierre Gosset, MD, GHICL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 31, 2013

Study Completion (Actual)

December 31, 2013

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 31, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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