NCT02220387|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
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 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 and associations 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-α (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.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 11, 2014
Actual (reported)August 19, 2014
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)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 will be calculated for each occupational group. Controls - healthy people.
1 day (a single measurement)
Difference 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)
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 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.
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 polycyclic aromatic hydrocarbons exhaust
Consists of 2 subgroups 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 polycyclic aromatic hydrocarbons exhaust 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 Citi Hospital #2, Novosibirsk State Medical University
352 participants (actual enrollment reported by the registry).
First Submitted
August 11, 2014
First Posted
August 19, 2014
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
High Risk Populations Among COPD Patients in Japan
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)
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)
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Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
October 6, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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