Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

Biomarkers Clinical Trial

— Aerotox-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608293
• Other study ID #: RC-P0014
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 31, 2013

Study information

• Verified date: July 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2013
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomarkers
• Human Bronchial Epithelial Cells
• Lung Pathogenesis
• Smokers

Intervention

Diagnostic Test:
• Broncho Alveolar Lavages (BAL)
BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Université du Littoral Côte d’Opale, France

Outcome

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