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

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

Study Overview

• Status: Unknown
• Conditions: Silicosis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Pulmonary Laboratory of Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

At least six months of occupational exposure to Caesar stone

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
exposed workers; At least six months of occupational exposure to Caesar stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: February 6, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (ESTIMATE): April 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 5, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Silicosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Silicosis
• Other Study ID Numbers: TASMC-11-YS-620-CTIL