Silicosis Clinical Trial
Official title:
Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
Silicosis is well-known occupational disease caused by free crystalline silica (silicon
dioxide) and is marked by inflammation and pulmonary fibrosis. There are cumulative
evidences that exposure to Caesar stone (quartz surface products that manufactured from up
to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers.
Goals: To examine marble workers exposed to Caesar Stone in order to propose a working plan
of surveillance and prevention by biological monitoring.
Study participants would be recruited during two years of the study. They will be asked to
come to a single visit at Pulmonary Laboratory of Tel Aviv Medical Center. During the
meeting, participants will be given a precise explanation about the tests they will perform
and after signing the informed consent will perform following tests:
1. Induced sputum (IS) - will be done after pretreatment with short acting beta-2 agonist
and 3% saline will be administrated by an ultrasonic nebulizer for up to 20 min.
Differential cell count, particle size distribution test of the particulate matter
(with a Eyetech Analyzer (Ankersmid, Yokneam, Israel)will be done from IS samples and
evaluation the activity of Heme oxygenase 1 (HO-1) protein from IS supernatants.
2. EBC-Exhaled Breath Condensate-will be done by condensation expiratory air and
particulate matter and markers of oxidation will be measured.
3. Participants will be asked to complete occupational questionnaire.
4. Pulmonary function tests (PFTs): The measurement will be performed using standard
protocols according to American Thoracic Society/European Respiratory Society (ATS/ERS)
guidelines. Including Lung diffusion testing.
Laboratory tests of induced sputum and EBC will be done within a week of a participant
visit. Analysis of data will be done after the completion of data collection and laboratory
tests.
;
Time Perspective: Cross-Sectional
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT01329003 -
DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)
|
N/A | |
Recruiting |
NCT04161014 -
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
|
Phase 2 | |
Recruiting |
NCT05118256 -
Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis
|
Phase 2 | |
Completed |
NCT02430259 -
Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention
|
Phase 3 | |
Recruiting |
NCT06403800 -
Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania
|
||
Not yet recruiting |
NCT06011785 -
Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil
|
Early Phase 1 | |
Not yet recruiting |
NCT05402176 -
The SHIELD Whole Lung Lavage Study
|
||
Completed |
NCT02794701 -
Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
|
||
Completed |
NCT01977131 -
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
|
Phase 1/Phase 2 | |
Completed |
NCT00005280 -
Specialized Center of Research in Occupational and Immunologic Lung Disease
|
N/A | |
Recruiting |
NCT05538299 -
Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials
|
||
Completed |
NCT01725971 -
Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis
|
N/A | |
Recruiting |
NCT06090370 -
Reducing Silica Exposure Among Brick Kiln Workers in Nepal
|
N/A | |
Completed |
NCT04205708 -
Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
|
||
Recruiting |
NCT05546944 -
The SHIELD Study-silicosis
|