DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)

Silicosis Clinical Trial

Official title:

DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01329003
• Other study ID #: TASMC-11-YS-620-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2011
• Last updated: April 1, 2011
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: March 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 correlation between disease and exposure to Caesar stone and genetic differences regarding genes involved in oxidative stress to understand Genetic susceptibility

Description:

It is a sub-study of "DNA-damage biomarkers to monitor and early detect health impairment in workers exposed to Silica (Caesar Stone)" study. 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)

2. Exhaled Breath Condensate

3. Pulmonary function tests (PFTs)

4. Participants will be asked to complete occupational questionnaire

Genetic studies (DNA) will be done from peripheral blood samples (20 ml) to study differences in Heme oxygenase 1 (HO-1) gene sequencing between participants with evidences of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines and participants without evidences of clinically definite silicosis.DNA samples will be obtained and coded in the same day of a participant visit and after collecting reasonable amount of samples examination of genes of interest will be done.Analysis of data will be done after the completion of data collection and laboratory tests.

Each sample will be given specific code to protect confidentiality of participants. Blood samples, test results and the code key will be kept in different places and only few research staff will have the accessibility to genetic information. In any case employers or any other persons that not included in research staff will not have any accessibility to this information. In this study genetic analysis is not connected to gender, nationality or any other social feature.

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 American Thoracic Society/European Respiratory Society (ATS/ERS)guidelines	Occupational physician examination; 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; Computed Tomography (CT) test if need	one day	No
Secondary	Differences in Heme oxygenase 1 (HO-1) gene sequencing	Genetic studies (DNA) will be done from peripheral blood samples (20 ml) to study differences in Heme oxygenase 1 (HO-1) gene sequencing between participants with evidences of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines and participants without evidences of clinically definite silicosis	one day	No