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临床试验/NCT03240198
NCT03240198Unknown不适用

Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles

Centre Hospitalier Intercommunal Creteil1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
C Protein Reactive

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate with modification of protease-antiprotease and oxidant-antioxydant balances. Local modifications are associated with systemic changes. Many occupational factors have been associated with an excess of COPD in epidemiological studies, however without identification of any specific clinical or biological phenotype.

Pathophysiological pathways involved in COPD might be different according to etiologic agents. Therefore, it is important to focus research on blood biomarkers associated with some well-characterized occupational COPD.

The objectives of MB2PROF project are:

  1. To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,
  2. To study the evolution of clinical and lung function parameters of occupational COPD in comparison with non occupational COPD during a follow-up study,
  3. To identify biological phenotypes of COPD associated to a given etiological agent.

The methodology includes:

  1. The constitution of a cohort with a clinical and biological follow-up during 5 years. Subjects will be recruited in 7 occupational diseases departments, with the collaboration of Pneumology departments.

Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60 subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical data, lung function parameters, occupation history and blood samples will be collected. 2. The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD, 3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo studies The MB2PROF project is an original and ambitious multidisciplinary and translational project. The constitution of well-characterized COPD cases cohort should allow the identification of biomarkers and molecular pathways associated with some subgroup of subjects, and improve the knowledge of mechanisms involved.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Other obstructive disease

结局指标

主要结局

C Protein Reactive

时间窗: at year 1

blood inflammatory markers

时间窗: at year 1

次要结局

  • C Protein Reactive(every year during 5 years)
  • blood inflammatory markers(every year during 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pascal ANDUJAR

Principal Investigator

Centre Hospitalier Intercommunal Creteil

研究点 (1)

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