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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
  Purpose

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
Silicosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
  1. Induced sputum (IS)
  2. Exhaled Breath Condensate

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
exposed workers
At least six months of occupational exposure to Caesar stone

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

At least six months of occupational exposure to Caesar stone

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338064

Contacts
Contact: Daria Bliznuk, BSc 972-0506353669 dasha_bl@yahoo.com
Contact: Elizabeth Fairman, professor 972-3-6973988 lizif@tasmc.health.gov.il

Locations
Israel
Pulmonary Laboratory of Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Daria Bliznuk, BSc     972-0506353669     dasha_bl@yahoo.com    
Contact: Elizabeth Fierman, professor     972-3-6973988     lizif@tasmc.health.gov.il    
Sub-Investigator: Elizabeth Fierman, professor            
Principal Investigator: Yehuda Shwartz, MD            
Sub-Investigator: Mordehai Kremer, professor            
Sub-Investigator: Daria Bliznuk, BSc            
Sub-Investigator: Irina Golov, Ms            
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
  More Information

No publications provided

Responsible Party: Elizabeth Fairman, Tel Aviv medical center
ClinicalTrials.gov Identifier: NCT01338064     History of Changes
Other Study ID Numbers: TASMC-11-YS-619-CTIL
Study First Received: February 6, 2011
Last Updated: April 16, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Tel-Aviv Sourasky Medical Center:
Silicosis

Additional relevant MeSH terms:
Silicosis
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
 Respiratory Tract Diseases
Lung Injury
Occupational Diseases

ClinicalTrials.gov processed this record on May 16, 2013