ClinicalTrials.gg
Status unknownNCT01338064Updated Apr 19, 2011

Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)

An observational study in Silicosis, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-19.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 70 Years
Sex
Male
01

Study 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 marble workers exposed to Caesar Stone in order to propose a working plan of surveillance and prevention by biological monitoring.

Read the detailed description

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) - will be done after pretreatment with short acting beta-2 agonist and 3% saline will be administrated by an ultrasonic nebulizer for up to 20 min. Differential cell count, particle size distribution test of the particulate matter (with a Eyetech Analyzer (Ankersmid, Yokneam, Israel)will be done from IS samples and evaluation the activity of Heme oxygenase 1 (HO-1) protein from IS supernatants.
  2. EBC-Exhaled Breath Condensate-will be done by condensation expiratory air and particulate matter and markers of oxidation will be measured.
  3. Participants will be asked to complete occupational questionnaire.
  4. 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.

Laboratory tests of induced sputum and EBC will be done within a week of a participant visit. Analysis of data will be done after the completion of data collection and laboratory tests.

02

Conditions studied

  • Silicosis

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Keywords

  • Silicosis
03

In context

Silicosis

20 studies on the registry are indexed under Silicosis; 3 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 11 observational studies indexed under Silicosis.

Browse Silicosis studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

At least six months of occupational exposure to Caesar stone

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. male
  2. 18-70 years old
  3. At least six months of professional exposure to Caesar stone

Exclusion criteria

Exclusion Criteria:

  1. Other occupational exposure (welding of any kind)
  2. (COPD), tuberculosis, asthma, disease in healthy exposed workers
  3. Interstitial lung disease in exposed workers with clinically approved silicosis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • exposed workers

    At least six months of occupational exposure to Caesar stone

06

What researchers measure

Primary outcomes

  1. Evidence of clinically definite silicosis according to ATS/ERS guidelines

    1. Occupational physician examination 2. Pulmonary function tests (PFTs): The measurement will be performed using standard protocols according to ARS/ERS guidelines. Including Lung diffusion testing 3. Computed Tomography (CT) test if need

    Time frame: one day

Secondary outcomes

  1. Particle size distribution of the particulate matter

    Particle size distribution test of the particulate matter (with a Eyetech Analyzer (Ankersmid, Yokneam, Israel) will be done from Induced sputum (IS) samples and EBC-Exhaled Breath Condensate.

    Time frame: one day

  2. The activity of Heme oxygenase 1 (HO-1) protein

    Evaluation the activity of Heme oxygenase 1 (HO-1) protein will be done from Induced sputum (IS) supernatants.

    Time frame: one day

  3. Differential cell count

    Differential cell count will be done from Induced sputum (IS) samples.

    Time frame: one day

  4. Markers of oxidation

    Markers of oxidation will be measured will be measured in EBC-Exhaled Breath Condensate.

    Time frame: one day

07

Study locations

1 site
  • Pulmonary Laboratory of Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
    • Daria Bliznuk, BSc · Contactdasha_bl@yahoo.com · 972-0506353669
    • Elizabeth Fierman, professor · Contactlizif@tasmc.health.gov.il · 972-3-6973988
    • Elizabeth Fierman, professor · Sub investigator
    • Yehuda Shwartz, MD · Principal investigator
    • Mordehai Kremer, professor · Sub investigator
    • Daria Bliznuk, BSc · Sub investigator
    • Irina Golov, Ms · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01338064
First posted
Apr 19, 2011
Start date
Sep 2011
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Apr 19, 2011

Study contacts

Daria Bliznuk, BSc
Contact
dasha_bl@yahoo.com
972-0506353669
Elizabeth Fairman, professor
Contact
lizif@tasmc.health.gov.il
972-3-6973988
Yehuda Shwartz, MD
principal investigator · Tel Aviv medical center. Pulmonary and Allergy department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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