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Biological Markers for Professional COPD (MB2PROF)

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ClinicalTrials.gov Identifier: NCT03240198
Recruitment Status : Unknown
Verified August 2017 by Pascal ANDUJAR, Centre Hospitalier Intercommunal Creteil.
Recruitment status was:  Recruiting
First Posted : August 7, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier Le Havre
Henri Mondor University Hospital
Information provided by (Responsible Party):
Pascal ANDUJAR, Centre Hospitalier Intercommunal Creteil

Study Description
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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.

Condition or disease
Copd

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Marqueurs Biologiques Des Bronchopneumopathies Chroniques Obstructives Professionnelles
Study Start Date : January 2010
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : January 2021
Groups and Cohorts
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Group/Cohort
COPD
Controls


Outcome Measures
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Primary Outcome Measures :
  1. C Protein Reactive [ Time Frame: at year 1 ]
  2. blood inflammatory markers [ Time Frame: at year 1 ]

Secondary Outcome Measures :
  1. C Protein Reactive [ Time Frame: every year during 5 years ]
  2. blood inflammatory markers [ Time Frame: every year during 5 years ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
COPD and healthy subjects exposed to tobacco smoking and/or to occupational dust
Criteria

Inclusion Criteria:

  • COPD

Exclusion Criteria:

  • Other obstructive disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240198


Locations
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France
CHI Créteil Recruiting
Créteil, France, 94000
Contact: Pascal Andujar, MD PhD    33 1 57 02 20 95    pascal.andujar@chicreteil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Centre Hospitalier Universitaire de Besancon
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Lille
Centre Hospitalier Le Havre
Henri Mondor University Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Pascal ANDUJAR, Principal Investigator, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03240198    
Other Study ID Numbers: MB2PROF
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Keywords provided by Pascal ANDUJAR, Centre Hospitalier Intercommunal Creteil:
occupational
cohort
biomarkers