Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
1 other identifier
observational
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
1 active site
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
First Submitted
Initial submission to the registry
February 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 19, 2011
April 1, 2011
2 years
February 6, 2011
April 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of clinically definite silicosis according to ATS/ERS guidelines
1. Occupational physician examination 2. Pulmonary function tests (PFTs): The measurement will be performed using standard protocols according to ARS/ERS guidelines. Including Lung diffusion testing 3. Computed Tomography (CT) test if need
one day
Secondary Outcomes (4)
Particle size distribution of the particulate matter
one day
The activity of Heme oxygenase 1 (HO-1) protein
one day
Differential cell count
one day
Markers of oxidation
one day
Study Arms (1)
exposed workers
At least six months of occupational exposure to Caesar stone
Eligibility Criteria
At least six months of occupational exposure to Caesar stone
You may qualify if:
- male
- years old
- At least six months of professional exposure to Caesar stone
You may not qualify if:
- Other occupational exposure (welding of any kind)
- Chronic Obstructive Pulmonary Disease (COPD), tuberculosis, asthma, autoimmune disease in healthy exposed workers
- Interstitial lung disease in exposed workers with clinically approved silicosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Rabin Medical Centercollaborator
Study Sites (1)
Pulmonary Laboratory of Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Biospecimen
1. Induced sputum (IS) 2. Exhaled Breath Condensate
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yehuda Shwartz, MD
Tel Aviv medical center. Pulmonary and Allergy department
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 6, 2011
First Posted
April 19, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
April 19, 2011
Record last verified: 2011-04