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

NCT01329003 | Unknown

• 1 other identifier: TASMC-11-YS-620-CTIL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Silicosis

Keywords

Silicosis

Outcome Measures

Primary Outcomes (1)

• Evidence of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS)guidelines

  1. 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

  one day

Secondary Outcomes (1)

• Differences in Heme oxygenase 1 (HO-1) gene sequencing

  one day

Study Arms (1)

exposed workers

At least six months of occupational exposure to Caesar stone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At least six months of occupational exposure to Caesar stone

You may qualify if:

• male
• years old
• At least six months of professional exposure to Caesar stone

You may not qualify if:

• Other occupational exposure (welding of any kind)
• Chronic Obstructive Pulmonary Disease (COPD), tuberculosis, asthma, autoimmune disease in healthy exposed workers
• Interstitial lung disease in exposed workers with clinically approved silicosis

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Rabin Medical Center: collaborator

Study Sites (1)

Pulmonary Laboratory of Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood 20 ml(cc)

MeSH Terms

Conditions

Silicosis

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• Yehuda Shwartz, MD

  Tel Aviv medical center. Pulmonary and Allergy department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daria Bliznuk, BSc

CONTACT

972-0506353669; dasha_bl@yahoo.com

Elizabeth Fairman, professor

CONTACT

972-3-6973988; lizif@tasmc.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 6, 2011
• First Posted: April 5, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 5, 2011

Record last verified: 2011-03

Locations

IL (1)