NCT02284295|Completed
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Sponsor study identifier
Secondary identifiers
OTHER · Education and Science Ministry of Russian Federation
observational
352
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor alpha (TNF α) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2014
Actual (reported)November 2014
Actual (reported)November 3, 2014
Actual (reported)November 6, 2014
Actual (reported)Difference in serum interleukin 1 beta (IL-1β) level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in serum tumor necrosis factor alpha (TNFα) level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in spontaneous thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in collagen induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by hsCRP and TNF α serum concentration, in different occupational COPD groups.
1 day (a single measurement)
Consists of 2 subgroups 1. COPD patients with history of exposure to respirable silica dust 2. COPD patients with history of exposure to aromatic hydrocarbons
1. patients with COPD, history of tobacco smoke and no history of occupational exposure 2. healthy subjects
History of exposure to respirable silica dust due to job
history of exposure to aromatic hydrocarbons due to job
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Residents of a certain town (Novosibirsk, Russian Federation)
Novosibirsk City Hospital #2
Novosibirsk, 630084, Russia
whole blood, serum,bronchoalveolar lavage fluid
Liubov Shpagina, PhD
Novosibirsk City Hospital #2, Novosibirsk State Medical University
352 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2014
First Posted
November 6, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
High Risk Populations Among COPD Patients in Japan
Difference in epinephrine induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in adenosine diphosphate induced thrombocyte aggregation between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in fibrinogen level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in fibrinogen degradation products level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in D-dimer level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in serum endothelin1 level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Difference in serum nitric oxide level between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Differences in cytological analysis of bronchoalveolar lavage fluid results between COPD patients exposed to dust, chemicals and tobacco smoke
Comparison of groups
1 day (a single measurement)
Association of SNPs rs1800470 TGF β1 gene, rs1828591 HHIP gene, rs4129267 IL-6R gene, rs1051730 CHRNA3 gene with COPD in subjects exposed to dust and in those exposed to chemicals. (Odds ratio and 95% confidence interval)
Odds ratio and 95% confidence interval will be calculated for each occupational group. Controls - healthy people.
1 day (a single measurement)
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Primary Completion
November 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
April 14, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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