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Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)

Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01338064
Enrollment
150
Registered
2011-04-19
Start date
2011-09-30
Completion date
2013-09-30
Last updated
2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Silicosis

Keywords

Silicosis

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.

Detailed description

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.

Interventions

None listed

Sponsors

Rabin Medical Center
CollaboratorOTHER
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. male 2. 18-70 years old 3. At least six months of professional exposure to Caesar stone

Exclusion criteria

1. Other occupational exposure (welding of any kind) 2. Chronic Obstructive Pulmonary Disease (COPD), tuberculosis, asthma, autoimmune disease in healthy exposed workers 3. Interstitial lung disease in exposed workers with clinically approved silicosis

Design outcomes

Primary

MeasureTime frameDescription
Evidence of clinically definite silicosis according to ATS/ERS guidelinesone day1. 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

Secondary

MeasureTime frameDescription
Particle size distribution of the particulate matterone dayParticle size distribution test of the particulate matter (with a Eyetech Analyzer (Ankersmid, Yokneam, Israel) will be done from Induced sputum (IS) samples and EBC-Exhaled Breath Condensate.
The activity of Heme oxygenase 1 (HO-1) proteinone dayEvaluation the activity of Heme oxygenase 1 (HO-1) protein will be done from Induced sputum (IS) supernatants.
Differential cell countone dayDifferential cell count will be done from Induced sputum (IS) samples.
Markers of oxidationone dayMarkers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.

Countries

Israel

Contacts

Primary ContactDaria Bliznuk, BSc
dasha_bl@yahoo.com972-0506353669
Backup ContactElizabeth Fairman, professor
lizif@tasmc.health.gov.il972-3-6973988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026