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

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01338064
Collaborator
Rabin Medical Center (Other)
150
Enrollment
1
Location
24
Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
    Study Start Date :
    Sep 1, 2011
    Anticipated Primary Completion Date :
    Sep 1, 2013
    Anticipated Study Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    exposed workers

    At least six months of occupational exposure to Caesar stone

    Outcome Measures

    Primary Outcome Measures

    1. Evidence of clinically definite silicosis according to ATS/ERS guidelines [one day]

      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

    Secondary Outcome Measures

    1. Particle size distribution of the particulate matter [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.

    2. The activity of Heme oxygenase 1 (HO-1) protein [one day]

      Evaluation the activity of Heme oxygenase 1 (HO-1) protein will be done from Induced sputum (IS) supernatants.

    3. Differential cell count [one day]

      Differential cell count will be done from Induced sputum (IS) samples.

    4. Markers of oxidation [one day]

      Markers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pulmonary Laboratory of Tel Aviv Sourasky Medical Center Tel Aviv Israel

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center
    • Rabin Medical Center

    Investigators

    • Principal Investigator: Yehuda Shwartz, MD, Tel Aviv medical center. Pulmonary and Allergy department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01338064
    Other Study ID Numbers:
    • TASMC-11-YS-619-CTIL
    First Posted:
    Apr 19, 2011
    Last Update Posted:
    Apr 19, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    Silicosis
    Additional relevant MeSH terms:
    Silicosis

    Study Results

    No Results Posted as of Apr 19, 2011