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

This study is not yet open for participant recruitment.
Verified April 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01338064
First received: February 6, 2011
Last updated: April 16, 2011
Last verified: April 2011
History of Changes

February 6, 2011
April 16, 2011
September 2011
September 2013   (final data collection date for primary outcome measure)
Evidence of clinically definite silicosis according to ATS/ERS guidelines [ Time Frame: one day ] [ Designated as safety issue: No ]
  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
Same as current
Complete list of historical versions of study NCT01338064 on ClinicalTrials.gov Archive Site
  • Particle size distribution of the particulate matter [ Time Frame: one day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Differential cell count will be done from Induced sputum (IS) samples.
  • Markers of oxidation [ Time Frame: one day ] [ Designated as safety issue: No ]
    Markers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.
Same as current
Not Provided
Not Provided
 
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)

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 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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:
  1. Induced sputum (IS)
  2. Exhaled Breath Condensate
Non-Probability Sample

At least six months of occupational exposure to Caesar stone
Silicosis
Not Provided
exposed workers
At least six months of occupational exposure to Caesar stone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact: Daria Bliznuk, BSc 972-0506353669 dasha_bl@yahoo.com
Contact: Elizabeth Fairman, professor 972-3-6973988 lizif@tasmc.health.gov.il
Israel
 
NCT01338064
TASMC-11-YS-619-CTIL
No
Elizabeth Fairman, Tel Aviv medical center
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Principal Investigator: Yehuda Shwartz, MD Tel Aviv medical center. Pulmonary and Allergy department
Tel-Aviv Sourasky Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP