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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01329003
First received: February 6, 2011
Last updated: April 1, 2011
Last verified: March 2011
  Purpose

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


Condition
Silicosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Evidence of clinically definite silicosis according to American Thoracic Society/European Respiratory Society (ATS/ERS)guidelines [ Time Frame: one day ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Differences in Heme oxygenase 1 (HO-1) gene sequencing [ Time Frame: one day ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

blood 20 ml(cc)


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
exposed workers
At least six months of occupational exposure to Caesar stone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

At least six months of occupational exposure to Caesar stone

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329003

Contacts
Contact: Daria Bliznuk, BSc 972-0506353669 dasha_bl@yahoo.com
Contact: Elizabeth Fairman, professor 972-3-6973988 lizif@tasmc.health.gov.il

Locations
Israel
Pulmonary Laboratory of Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Daria Bliznuk, BSc    972-0506353669    dasha_bl@yahoo.com   
Contact: Elizabeth Fierman, professor    972-3-6973988    lizif@tasmc.health.gov.il   
Sub-Investigator: Elizabeth Fierman, professor         
Principal Investigator: Yehuda Shwartz, MD         
Sub-Investigator: Mordehai Kremer, professor         
Sub-Investigator: Daria Bliznuk, BSc         
Sub-Investigator: Irina Golov, Ms         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Rabin Medical Center
Investigators
Principal Investigator: Yehuda Shwartz, MD Tel Aviv medical center. Pulmonary and Allergy department
  More Information

No publications provided

Responsible Party: Elizabeth Fairman, Tel Aviv medical center
ClinicalTrials.gov Identifier: NCT01329003     History of Changes
Other Study ID Numbers: TASMC-11-YS-620-CTIL
Study First Received: February 6, 2011
Last Updated: April 1, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Tel-Aviv Sourasky Medical Center:
Silicosis

Additional relevant MeSH terms:
Silicosis
Lung Diseases
Lung Diseases, Interstitial
Lung Injury
Occupational Diseases
Pneumoconiosis
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014