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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (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 Summary:

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.


Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome: Evidence of clinically definite silicosis according to ATS/ERS guidelines [ Time Frame: one day ]

  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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: February 6, 2011
Date Started: September 2011
Date Completion: September 2013
Last Updated: April 16, 2011
Last Verified: April 2011