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

Silicosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01338064
• Other study ID #: TASMC-11-YS-619-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2011
• Last updated: April 16, 2011
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Daria Bliznuk, BSc
• Phone: 972-0506353669
• Email: dasha_bl[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Silicosis

Locations

Country	Name	City	State
Israel	Pulmonary Laboratory of Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite silicosis according to ATS/ERS guidelines	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	one day	No
Secondary	Particle size distribution of the particulate matter	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.	one day	No
Secondary	The activity of Heme oxygenase 1 (HO-1) protein	Evaluation the activity of Heme oxygenase 1 (HO-1) protein will be done from Induced sputum (IS) supernatants.	one day	No
Secondary	Differential cell count	Differential cell count will be done from Induced sputum (IS) samples.	one day	No
Secondary	Markers of oxidation	Markers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.	one day	No