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OpenTrials
Completed

NCT Number: NCT03608293

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, the main goal is to study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broncho Alveolar Lavages (BAL)

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Collaborators

  • Universite du Littoral Cote d'Opale

Registry information

Official study title

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

Acronym: Aerotox-1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2018
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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