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

Status Not yet recruiting

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

Clinical Trial 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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Silicosis

Clinical Trial Details

NCT number	NCT01329003
Study type	Observational
Source	Tel-Aviv Sourasky Medical Center
Contact	Daria Bliznuk, BSc
Phone	972-0506353669
Email	dasha_bl@yahoo.com
Status	Not yet recruiting
Phase	N/A
Start date	September 2011
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT05118256` - Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis	Phase 2
Completed	`NCT02430259` - Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention	Phase 3
Recruiting	`NCT06403800` - Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania
Not yet recruiting	`NCT06011785` - Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil	Early Phase 1
Not yet recruiting	`NCT05402176` - The SHIELD Whole Lung Lavage Study
Completed	`NCT02794701` - Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
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Completed	`NCT00005280` - Specialized Center of Research in Occupational and Immunologic Lung Disease	N/A
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Completed	`NCT01725971` - Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis	N/A
Recruiting	`NCT06090370` - Reducing Silica Exposure Among Brick Kiln Workers in Nepal	N/A
Completed	`NCT04205708` - Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Recruiting	`NCT05546944` - The SHIELD Study-silicosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.