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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01329003
Enrollment
150
Registered
2011-04-05
Start date
2011-09-30
Completion date
2013-09-30
Last updated
2011-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Silicosis

Keywords

Silicosis

Brief 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

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.

Interventions

None listed

Sponsors

Rabin Medical Center
CollaboratorOTHER
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evidence of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS)guidelinesone day1. Occupational physician examination 2. 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 3. Computed Tomography (CT) test if need

Secondary

MeasureTime frameDescription
Differences in Heme oxygenase 1 (HO-1) gene sequencingone dayGenetic 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

Countries

Israel

Contacts

Primary ContactDaria Bliznuk, BSc
dasha_bl@yahoo.com972-0506353669
Backup ContactElizabeth Fairman, professor
lizif@tasmc.health.gov.il972-3-6973988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026