Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
Aerotox-1
Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2013
CompletedFirst Submitted
Initial submission to the registry
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedJuly 31, 2018
July 1, 2018
1.6 years
July 24, 2018
July 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Smokers
EXPERIMENTALSmokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed
Non smokers
ACTIVE COMPARATORNon smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed
Interventions
BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.
Eligibility Criteria
You may qualify if:
- \>18 year-old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lille Catholic Universitylead
- Universite du Littoral Cote d'Opalecollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Gosset, MD
GHICL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2018
First Posted
July 31, 2018
Study Start
January 1, 2012
Primary Completion
July 31, 2013
Study Completion
December 31, 2013
Last Updated
July 31, 2018
Record last verified: 2018-07