Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
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|ClinicalTrials.gov Identifier: NCT01338064|
Recruitment Status : Unknown
Verified April 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
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|
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:
- 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.
- EBC-Exhaled Breath Condensate-will be done by condensation expiratory air and particulate matter and markers of oxidation will be measured.
- Participants will be asked to complete occupational questionnaire.
- 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|
|Estimated Enrollment :||150 participants|
|Official Title:||Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
At least six months of occupational exposure to Caesar stone
- Evidence of clinically definite silicosis according to ATS/ERS guidelines [ Time Frame: 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
- 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.
Biospecimen Retention: Samples Without DNA
- Induced sputum (IS)
- Exhaled Breath Condensate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338064
|Contact: Daria Bliznuk, BScemail@example.com|
|Contact: Elizabeth Fairman, firstname.lastname@example.org|
|Pulmonary Laboratory of Tel Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel|
|Contact: Daria Bliznuk, BSc 972-0506353669 email@example.com|
|Contact: Elizabeth Fierman, professor 972-3-6973988 firstname.lastname@example.org|
|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|
|Principal Investigator:||Yehuda Shwartz, MD||Tel Aviv medical center. Pulmonary and Allergy department|