Clinical trial NCT01338064: Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
Official title: Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Silicosis
Keywords: Silicosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Rabin Medical Center
First posted: 2011-04-19
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least six months of occupational exposure to Caesar stone

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of clinically definite silicosis according to ATS/ERS guidelines
timeFrame: one day
Secondary outcomes:
measure: Particle size distribution of the particulate matter
timeFrame: one day
measure: The activity of Heme oxygenase 1 (HO-1) protein
timeFrame: one day
measure: Differential cell count
timeFrame: one day
measure: Markers of oxidation
timeFrame: one day
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pulmonary Laboratory of Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel Aviv medical center. Pulmonary and Allergy department
name: Yehuda Shwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: