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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01338064
Other study ID # TASMC-11-YS-619-CTIL
Secondary ID
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


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
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