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 Overview

• Status: Unknown
• Conditions: Silicosis

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Pulmonary Laboratory of Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

At least six months of occupational exposure to Caesar stone

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
exposed workers; At least six months of occupational exposure to Caesar stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of clinically definite silicosis according to ATS/ERS guidelines	Occupational physician examination; Pulmonary function tests (PFTs): The measurement will be performed using standard protocols according to ARS/ERS guidelines. Including Lung diffusion testing; Computed Tomography (CT) test if need	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Particle size distribution of the particulate matter	Particle 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.	one day
The activity of Heme oxygenase 1 (HO-1) protein	Evaluation the activity of Heme oxygenase 1 (HO-1) protein will be done from Induced sputum (IS) supernatants.	one day
Differential cell count	Differential cell count will be done from Induced sputum (IS) samples.	one day
Markers of oxidation	Markers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.	one day

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: February 6, 2011
• First Submitted That Met QC Criteria: April 16, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 16, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Silicosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Silicosis
• Other Study ID Numbers: TASMC-11-YS-619-CTIL