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Clinical Trials/NCT03240198
NCT03240198
Unknown
Not Applicable

Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles

Centre Hospitalier Intercommunal Creteil1 site in 1 country400 target enrollmentJanuary 2010
ConditionsCopd

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Copd
Sponsor
Centre Hospitalier Intercommunal Creteil
Enrollment
400
Locations
1
Primary Endpoint
C Protein Reactive
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2021
Last Updated
8 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pascal ANDUJAR

Principal Investigator

Centre Hospitalier Intercommunal Creteil

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Other obstructive disease

Outcomes

Primary Outcomes

C Protein Reactive

Time Frame: at year 1

blood inflammatory markers

Time Frame: at year 1

Secondary Outcomes

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

Study Sites (1)

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