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Trial record 1 of 1 for:    NCT03608293
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Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells (Aerotox-1)

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ClinicalTrials.gov Identifier: NCT03608293
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Université du Littoral Côte d'Opale, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Smokers Human Bronchial Epithelial Cells Lung Pathogenesis Biomarkers Diagnostic Test: Broncho Alveolar Lavages (BAL) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : July 31, 2013
Actual Study Completion Date : December 31, 2013

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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608293


Sponsors and Collaborators
Lille Catholic University
Université du Littoral Côte d'Opale, France
Investigators
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Principal Investigator: Pierre Gosset, MD GHICL
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03608293    
Other Study ID Numbers: RC-P0014
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No